Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Phase: NA
Conditions: Sleep, Alzheimer Disease, Cognitive Impairment, Aging, CBT
Sponsor: University of California, San Francisco

 
 
 
 
 
 
Official title: Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease 
NCT#: NCT03256539 
Document date: 09/21/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
SleepTIGHT Study Protocol 
(Sleep Therapeutics Intervention to improve coGnitive HealTh) 
Full Study Title: Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease 
 
 
Principal Investigator: Yue Leng, PhD 
University of California, San Francisco 
675 18th Street 
San Francisco, CA 94107 
Phone: (415) 713-5916 
 
 
 
Sponsor 
 
National Institutes of Health 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Title 
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease (SleepTIGHT) 
 
Study Duration 
Trial duration: 9 weeks + follow-up after 24 weeks 
 
Study Center 
UCSF Psychiatry department 
Objective 
Determine feasibility of online CBT-I in an older adult population (age 65+)  
Number of Subjects 
40 
Diagnosis and Main Inclusion Criteria 
Inclusion Criteria 
• 
1) Age 65+,  
• 
2) evidence of MCI, defined as: self-reported quick dementia rating 
system (QDRS) - derived global clinical dementia rating score of .5,  
• 
3) adequate visual and auditory acquit to allow neuropsychological 
texting;  
• 
4) evidence of subthreshold or clinical insomnia, defined as a score of 8 
or more on the insomnia severity index,  
• 
5) ability to speak understand and write in English, 6) study partner 
willing to participate,  
• 
7) capacity to give written informed consent; and  
• 
8) owns one or more smartphone or tablet devices that can be used to 
access the internet and to participate in video conferences. 
 
Exclusion Criteria 
• 
1) Self-reported diagnosis by a physician of any major neurologic disease 
such as Alzheimer’s disease, other dementia, Parkinson’s disease, 
multiple sclerosis, epilepsy, Huntington’s disease;  
• 
2) History of brain tumor or significant head trauma (loss of 
consciousness >30 minutes); 
• 
3) Evidence (CT or MRI scans within 12 months prior to screening) of 
brain infarction or other focal lesions; 4) Any comorbid psychiatric 
conditions or severe personality disorder within the past 2 years (by 
DSM-V), such as major depression, bipolar disorder, schizophrenia, and 
other psychotic features;  
• 
5) Any uncontrolled medical conditions or systemic illness that might lead 
to difficulty complying with the study protocol;  
• 
6) Any concomitant treatment that might confound the results 
(participants must be off all psychotropic medications, including hypnotic 
medications, and non-pharmacological treatments, for at least 30 days 
prior to screening);  
• 
7) History of alcohol or substance abuse within the past 2 years;  
• 
8) Shift workers; and  
• 
9) Any inadequately treated primary or secondary sleep disorders 
 
 
 
 
 
 

 
 
 
 
STUDY PERSONNEL AND ROLES 
Yue Leng, PhD 
Principal Investigator 
Responsible for all study-related issues 
 
Purpose 
In order to address the hypothesis that CBT-I is feasible in patients with MCI, and could potentially improve their 
sleep quality, slow down cognitive decline, and improve quality of life of patients and caregivers, we will use a 
parallel-designed randomized controlled trial to pilot test the feasibility and effects of a digital CBT-I treatment 
program in those with MCI.  
 
This study focuses on testing the validity of this CBT-I program while exploring its preliminary effects on 
sleep/cognition.  
 
Duration of the Study 
Screening + Intervention + post-study screening: 10 – 13 weeks 
Post-treatment follow-up: After 24 weeks  
 
Setting 
The trial will take place remotely, with all activities and assessments done over phone or Zoom video call or app 
on smart device.  
 
Description of the Intervention 
We will randomize patients, using computer-generated random numbers, to one of two treatment arms:  
a) an FDA-authorized prescription digital CBT-I therapeutic treatment 
or 
b) an interactive, attention-matched, internet-based placebo control program.  
 
At the beginning of the intervention, study staff will give instructions on the use of the programs via zoom.  
Throughout the intervention, study staff will call the participants weekly to give further clarifications and answer 
questions. Somryst is a 9-week program that delivers digital CBT-I therapeutic content, and can be used on a 
mobile device, such as a smartphone or tablet. CBT-I is a neurobehavioral treatment which focuses on 
addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate sleep problems, 
regardless of the cause of sleep problems. CBT-I can be conceptualized as six sessions or cores that deliver 
proven behavioral and cognitive treatment strategies.  
 
Potential Benefits and Risks to Participants 
There will be no direct benefit to the participants from taking part in this study. Taking part in this study may or 
may not make their health better. While doctors hope that cognitive training therapies will be beneficial, these 
trainings are still being studied. 
 
 
 
 
 
 
 

 
 
 
Some of the most likely risks of participation in this study include: 
• Risk of fatigue/distress: Finding study activities difficult, tiring, time-consuming, anxiety-provoking, 
frustrating, or boring. Participants are free to decline to answer any questions or to stop at any time. To 
reduce fatigue, breaks are scheduled during testing and training sessions. Additional breaks will be 
provided at the participant’s request. If the participant appears to be under undue strain, the session will 
be discontinued. 
• Risk of loss of privacy: Participation in research may involve a loss of privacy. Because training takes place 
in a small group setting, other research subjects within the group may become aware of information that 
participants would prefer to not be shared outside of the group. Researchers will ask all subjects to keep 
private all information learned about other group members and to not talk about this information 
outside of group sessions. However, absolute confidentiality cannot be guaranteed. The researchers will 
keep information about participants as confidential as possible, but complete confidentiality cannot be 
guaranteed. On rare occasions, a court has subpoenaed research records. Other University of California 
personnel may also review or receive information about the participants. Study PI and research staff will 
retain the participant’s research records indefinitely for research purposes. Personal identifiable 
information (PII) and protected health information (PHI) cannot be used for additional research without 
additional approval from either the participant or a review committee. 
• Unknown risks: The experimental treatments may have risks or side effects that no one knows about yet. 
Members of the research team will inform participants about any new information that may impact their 
decision to remain in the study. 
Recruitment Methods 
Participants are recruited from MyChart patient records, screen in Computerized Patient Record System (CPRS), 
that meet inclusion criteria. Also, to be used:  Research Match and social media recruitment via advertisement 
on relevant pages associated to CPBH, i.e., Memory and Aging Center.  
Keywords checked in medical records:  
• Mild Cognitive Impairment 
• Age 65 or older 
• History of Insomnia 
• (Add final ICD-10 terms) 
Reasons for Participant Withdrawal or Termination 
Participants can decide to stop at any time. The study doctor may stop participants from taking part in this study 
at any time if the doctor believes it is in the participant’s best interest, if the participant does not follow study 
rules, or if the study is stopped 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Study Schedule & Procedure Summary 
SCHEDULE OF EVALUATIONS 
 
 
INITIAL CONTACT AND SCREENING  
1. Participants, after being identified or reaching out to research team with interest, will be called with 
initial contact phone script, given introductory information about the study, asked to confirm their  
 interest and given the option to fill consent form on same call or to schedule follow-up call for consent. 
IF participant it still interested, consent form is signed, then ISI questionnaire is given.  
 
2. Followed by appointment for: 
• Baseline Cognitive Assessment Interview: 1 hour via Zoom.  
• Administer the following questionnaires:  
▪ Pittsburg Sleep quality index  
▪ Epworth Sleepiness Scale  
▪ 36-item short-form survey 
 
If continued interest, eligible, and consented 
• Schedule meeting for briefing via Zoom on Somryst program or placebo condition materials 
• Intervention or attention-matched placebo program (6 weeks) + Weekly meetings with research team for 
clarification or assistance with materials and content 
 
 
 
ASSESSMENT 
Recruitment  
Pre-screening 
& Consent 
Screening/ 
Assessment 
Baseline Measures/ 
Start of Trial 
9 Weeks/ 
End of Trial 
Follow-up 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
Medical History 
X 
X 
 
 
Insomnia Severity Index 
X 
X 
 
X 
Pittsburg Sleep Quality 
Index 
 
X 
 
X 
SF-36 
 
 
X 
X 
Epworth Sleepiness Scale 
 
 
X 
X 
Quality of Life 
 
 
X 
X 
Cognitive function 
 
 
X 
X 
Geriatric Depression Scale 
 
 
X 
 
24-h Actigraphy  
(3 days) 
 
 
X 
X 
Cognitive Assessment 
Battery 
 
X 
X 
 
 

 
 
 
A. INTERVENTION  
Over six weeks, the research team will have scheduled meetings with participants to deliver content 
and instructions for use of the Somryst  
The Somryst program is intended to deliver 6 treatment Cores, with the following specific CBT-I 
therapy content:  
1. Get Ready: This Core sets the stage for the therapeutic experience. It lets the participant know 
what they will need to learn and do to improve sleep and sets goals for success.  
2. Sleep Window: This Core focuses on the concept of sleep restriction and identifies a Sleep Window 
- a recommended Bedtime and Arising Time – the participant should follow.  
3. Behaviors: This Core focuses on stimulus control and establishes guidelines for participants to 
follow while implementing their Sleep Window.  
4. Thoughts: This Core explains how a participant’s thinking can contribute to insomnia. The 
participant will learn to identify, and shift thought patterns.  
5. Education: This Core helps the participant identify changes to be made in their lifestyle and 
environment that can promote better sleep.  
6. Looking Ahead: This Core pulls together what the participant has learned, prepares the participant 
for the future, and teaches them what to do if they experience a relapse. Somryst also includes a daily 
Sleep Diary in which the participant records information about their sleep.  
 
B. FOLLOW-UP MEASURES 
        Once intervention is completed, 
• Feedback at the end of trial via survey and phone follow-up (if needed) 
• Follow-up (3-day actigraphy & questionnaires + Cognitive Assessments) 
• Follow-up at 24 weeks: 
• Final follow-up actigraphy watch measurement 
• Follow-up of cognitive assessment + questionnaires  
OUTCOME MEASURES 
Primary Outcomes 
Feasibility  
Proportion of eligible participants consented  
• Proportion of participants randomized after baseline assessment  
• Number of CBT-I sessions completed  
• 
Adherence/compliance rates  
• 
Follow-up rates  
• 
Missing data (data completeness)  
• 
Time needed to collect and analyze data  
Acceptability  
General study satisfaction  
Acceptability of intervention  
Barriers & Burden 
Qualitative interview  
 
 
 

 
 
 
Data Collection and Storage 
Patient information is collected and stored in REDCap. 
Once assessments are completed, they will be scored and recorded for later analysis.  
 
Study Outline Graphic  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
APPENDIX A. 
SLEEPTIGHT INITIAL CONTACT TELEPHONE SCREENER 
Full study title - Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease 
 
(For those who were pre-screened} 
 
_____ Hello, my name is _________ and I am calling about a research study called SleepTIGHT being conducted 
at UCSF by Principal Investigator Yue Leng, PhD. 
 
Is this a good time? Do you have time to talk for about five to seven minutes to learn briefly about our research 
study? 
 
If no: what would be a good time to call you? (Specify follow-up) ______________ 
 
If yes: Great! Broadly speaking, this research study is about digital therapeutics to treat sleep problems and 
improve cognition (Go to BRIEF STUDY OVERVIEW).  
 
[For calling back individuals who asked for more information]  
Hello, my name is __________. Thanks for expressing interest in our research study about sleep, insomnia, and 
cognitive decline. We appreciate you calling to learn more. The study is being conducted by researchers at the 
Department of Psychiatry and Behavioral Sciences at UCSF. We wanted to call today to tell you more about the 
study. Is this a good time? Do you have time to talk for about five to seven minutes to learn briefly about the 
study?  
BRIEF STUDY OVERVIEW 
Next, I’m going to give you a description of the study. Please stop me if you have any questions.  
 
As mentioned earlier, SleepTIGHT is a study using a digital therapeutic treatment for improving sleep patterns in 
people with mild impairment in mental processing. This study is unique in that it requires no in-person visits, and 
the therapy is FDA-approved. 
 
Participants will meet with researchers via phone and videoconference and undergo 6 weeks of (approx. 1 hour) 
sessions. You will be keeping a sleep diary to track progress and describe sleeping patterns over the course of 
the study.  You will also complete questionnaires that ask about your experience in the program, your quality of 
life, sleeping habits and mental processing.  
 
The primary goals with treatment are to improve sleep habits which may benefit your mental processing and 
slow or prevent risk for cognitive decline. 
 
If you are interested in enrolling, you will take part in a few questionnaires and cognitive tests. These are 
necessary to make sure you are eligible to participate. The screening questions will ask about your quality of life, 
overall health, mood, and sleep. We also will ask about cognitive function. These questionnaires will take about 
45 min – 1 hr.  for you to complete.  
 

 
 
 
After this, if you are interested and potentially eligible based on the screening, we will schedule a second 
appointment via videoconferencing to confirm your eligibility and complete necessary paperwork to begin the 
study.  
 
Are you still interested in participating? Do you have any questions? 
 
Would you like to do an initial screening for the study, or should I call back later? (it should take an additional 10-
15 minutes) 
 
 ***Please note that you are free not to answer any questions you are uncomfortable with, and otherwise 
please answer as accurately as possible (to best determine your eligibility).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
APPENDIX B.  
SleepTIGHT phone screening script 
 
INTERVIEWER INSTRUCTIONS 
 
Read bolded text verbatim. Answer any questions as needed. Record all contacts in the contact log.  
If a 
 is reached at any point, say: I’m sorry, but unfortunately you are not eligible to participate in this 
study. [Explain why they are not eligible if appropriate and indicate reason for ineligibility].  
 
☐ Not fluent in English   
☐ No diagnosis    
 
☐ No device to access content 
 
☐ Age < 18     
☐ Medical condition  
☐ Vision/hearing impairment    
☐ Psychiatric condition 
☐ Moderate/severe  
☐ Low QDRS 
☐ No study partner  
☐ Research study 
 
☐ Dementia medication change 
☐ Other __________  
 
 
INTRODUCTION 
Hi, this is _________ from the SleepTIGHT study.  
 
Describe how you got their name and phone number. E.g., ____ is a UCSF patient who expressed interest in our 
program; you recently contacted us about the SleepTIGHT study. Clarify that the program may also be known as 
Napping, Sleep, and Risk of Alzheimer’s Disease if necessary.  
 
Is this a good time for me to gather more information about your eligibility for the SleepTIGHT study? It 
should take about 20 minutes.  
 
☐ Yes  
☐ No  
 
 
If NO or NOT AVAILABLE:  
Schedule call-back 
Date___________ 
Time:________ 
 
 
If YES: 
*START HERE IF CONTINUING CALL* 
 
BACKGROUND INFORMATION 
 
Great! Before we get started, can you please tell me your name? [or confirm name if already known] 
___________________    
 
How did you learn about this study?  
☐ UCSF email/letter (1) ☐ Facebook/Social Media (2) ☐ Physician Referral (3) ☐ Recruitment Partners (4) ☐ 
Other (99) ___________ 
 
 

 
 
 
DEMOGRAPHIC INFORMATION 
How old are you? ________ years (enter as current age in whole years; 
 if under 65) 
 
Do you identify as male or female?   ☐ Male (0) 
☐ Female (1)    
☐ Other (8) ____________     Prefer not to answer (9) 
 
Do you identify as Hispanic or Latino?  
☐ Hispanic/Latino (1)    ☐ Not Hispanic/Latino (0) 
☒Other (7) _________    Prefer not to answer (8)  Unknown/Not Reported (9) _______   
 
 
What race or races do you consider yourself? (check all that apply) 
☐ White (1) 
☐ Asian (2)  
  ☐ Black or African American (3) 
☐ Native Hawaiian or Pacific Islander (4)  
☐ American Indian or Alaska Native (5) 
☐ Other (8) ____________ ☐ Unknown or Not Reported (9) 
   
  
   
How many years of school did you complete?  
Elementary: ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5 ☐ 6 ☐ 7  ☐ 8  
High school: ☐ 9 ☐ 10 ☐ 11 ☐ 12 ☐ GED 
College: ☐ 13 ☐ 14 ☐ 15 ☐ 16 
Post-graduate: ☐ 17 ☐ 18 ☐ 19 ☐ ≥20 
☐ Not sure 
 
ELIGIBILITY CRITERIA 
 
Are you able to speak and understand English?  
☐Yes (1)  ☐ No (0)   
If NO 
  
 
** Do you have a diagnosis related to memory loss? ☐ Alzheimer’s disease (1)  
☐ Vascular dementia (2)  ☐ Dementia unspecified (3)  ☐ Mixed dementia (4)   
☐ Mild cognitive impairment (5)   
☐ Not sure, but could ask doctor (6)   ☐ Other (7) _________ 
 
 
Do you have history of brain tumor or significant head trauma (including for instance, loss of consciousness 
>30 minutes?) 
☐Yes (1)  ☐ No (0)   
If YES 
  
 
Has a doctor ever diagnosed you with brain infarction? 
☐Yes (1)  ☐ No (0)   
If YES 
  
 
 
 
 

 
 
 
 
Has a doctor ever diagnosed you with any severe psychiatric disorders in the past 2 years such as depression, 
bipolar disorder, schizophrenia or any others? 
☐Yes (1)  ☐ No (0)   
If YES 
  
 
Specify which:   _______________ 
 
Has a doctor ever diagnosed you with any major neurological disease such as Parkinsons’ multiple schlerosis, 
epilepsy, or Huntington’s disease? 
☐Yes (1)  ☐ No (0)   
If YES 
  
 
Specify which: ____________ 
 
Has a doctor ever diagnosed you with Cognitive Impairment? 
☐Yes (1)  ☐ No (0)   
 
Has a doctor ever diagnosed you with Insomnia? 
☐Yes (1)  ☐ No (0)   
 
Have you been diagnosed with any sleep disorders (such as sleep apnea, sleep related movement disorders 
etc.)  (yes or no) if yes (have they been treated?)  
☐ No (0) 
☐ Yes (1)   
If Yes, please describe: ______. If YES 
 
 
Are you currently taking any medications for memory loss or dementia?  
☐Yes (1)  ☐ No (0)   
 
*If yes, please indicate which one(s) (check all that apply):  
☐ donepezil (Aricept)  
☐ galantamine (Razadyne) ☐ rivastigmine (Exelon) 
 
☐ memantine (Namenda) 
☐ other ________ 
 
Have you been on a steady dose for the past 3 months?  
☐Yes (1)  ☐ No (0)   If NO 
 
 
Are any changes to these medications planned in the next 6 months?  
☐Yes (1)  ☐ No (0)   If NO 
 
 
Have you been on any psychotropic or hypnotic medications within the past 30 days? 
☐ No (0) 
☐ Yes (1)  If YES 
 
please describe: ______.  
Do you have a history of alcohol or substance abuse within the past 2 years? 
☐ No (0) 
☐ Yes (1)   If YES 
 
 

 
 
 
Are you employed as a shift-worker? 
☐ No (0) 
☐ Yes (1)  If YES 
 
 
Do have vision or hearing impairment that could affect your ability to participate?  
☐ No (0) 
☐ Yes (1)   
If Yes, please describe: ______. 
 
 
The next questions will ask about what devices you could use for the online material and assessments.  
 
Do you have access to a device with a video camera that can connect to the internet? For example, an iPad, 
iPhone or other mobile device? Ineligible if they do not have a mobile device or tablet - our platform will only 
support those devices.  
  
☐ Yes (1) 
☐ No (0)  If UNSURE, gather more information and continue. 
☐ other (specify type: _________) Explain that camera access is only needed at certain times for cognitive 
testing and follow-up measures. Otherwise only a smartphone is needed.  
 
Are you willing to participate in the SleepTIGHT material for about 35 minutes on a weekly basis over six 
weeks? 
☐ Yes (1) 
☐ No (0) 
  
 
Are you currently participating in another research study?  
☐ No (0) 
☐ Yes (1)  If Yes, please describe: ______. 
 
Great, it looks like so far you are eligible to proceed – though we will need to do a few more tests to decide if 
you are eligible for the participation in the study. The next step is to conduct a screening for insomnia, and we 
will get back to you with your final eligibility.  
 
Subject’s Initials                  ID# 
           Date 
   Time 
AM/PM 
 
Please answer the following questions as accurately as possible. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
PITTSBURGH SLEEP QUALITY INDEX 
 
INSTRUCTIONS: 
The following questions relate to your usual sleep habits during the past month only. Your answers should 
indicate the most accurate reply for the majority of days and nights in the past month. 
Please answer all questions. 
 
1. 
During the past month, what time have you usually gone to bed at night? 
 
BED TIME _______________  
 
2. 
During the past month, how long (in minutes) has it usually taken you to fall asleep each night 
NUMBER OF MINUTES ______________  
3. 
During the past month, what time have you usually gotten up in the morning? 
GETTING UP TIME _______________ 
 
 
4. 
During the past month, how many hours of actual sleep did you get at night? (This may be different 
than the number of hours you spent in bed.) 
 
HOURS OF SLEEP PER NIGHT ______________ 
 
 
For each of the remaining questions, check the one best response. Please answer all questions. 
 
5. 
During the past month, how often have you had trouble sleeping because you . . . 
 
a) 
Cannot get to sleep within 30 minutes 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______
b) 
Wake up in the middle of the night or early morning 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______
 
c) 
Have to get up to use the bathroom 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______
 

 
 
 
d) 
Cannot breathe comfortably 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______
 
 
e) 
Cough or snore loudly 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______ 
 
f) 
Feel too hot 
 
Not during the 
 
Less than
 
Once or 
twice
 
Three 
or 
more 
last 
month ______    once a 
week______     a week______
 
times a 
week______ 
 
 
g) 
Had bad dreams 
 
Not during the 
 
Less than
 
Once or 
twice
 
Three 
or 
more 
last 
month ______    once a 
week______     a week______
 
times a 
week______ 
h) 
Have pain 
 
Not during the 
 
Less than
 
Once or 
twice
 
Three 
or 
more 
last 
month 
______    once a week______     
a week______ 
times a 
week______
 
i) 
Other reason(s), please describe 
__________________________________________________________________________________
__________________________________________________________________________________ 
How often during the past month have you had trouble sleeping because of this? 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______ 
 

 
 
 
6. 
During the past month, how would you rate your sleep quality overall? 
Very good     ______ 
 
Fairly good    ______ 
Fairly bad     ______ 
Very bad       ______ 
 
7. 
During the past month, how often have you taken medicine to help you sleep (prescribed or "over 
the counter")? 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______ 
 
 
8. 
During the past month, how often have you had trouble staying awake while driving, eating meals, 
or engaging in social activity? 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______ 
 
 
9. 
During the past month, how much of a problem has it been for you to keep up enough 
enthusiasm to get things done? 
No problem at all  
 
 
 
 
_____________ 
Only a very slight problem  
 
 
 
_____________ 
Somewhat of a problem  
 
 
 
_____________ 
A very big problem  
 
 
 
 
_____________ 
 
10. Do you have a bed partner or roommate? 
 
No bed partner or roommate  
 
 
_____________ 
 
Partner/roommate in other room 
 
 
_____________ 
 
Partner in same room, but not in same bed  
_____________ 
 
Partner in same bed  
 
 
 
_____________ 
 
 
 
 
 

 
 
 
 
 
If you have a roommate or bed partner, ask him/her how often in the past month you have had . . 
. 
 
a) 
Loud snoring 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______ 
 
 
b) 
Long pauses between breaths while asleep 
 
Not during the           Less than                          Once or twice           Three or more 
Past month_____     once a week_______      a week______          times a week________ 
 
c) 
Legs twitching or jerking while you sleep 
 
Not during the           Less than                          Once or twice           Three or more 
Past month_____     once a week_______      a week______          times a week________ 
 
d) 
Episodes of disorientation or confusion during sleep  
 
Not during the           Less than                          Once or twice           Three or more 
Past month_____     once a week_______      a week______          times a week________ 
 
e) 
Other restlessness while you sleep; please describe 
_____________________________________________________________________ 
 
Not during the  
Less than 
Once or twice 
Three or more 
last month ______    once a week______     a week______ 
times a week______ 
 

 
 
 
Insomnia Severity Index 
 
The Insomnia Severity Index has seven questions. The seven answers are added up to get a total 
score. When you have your total score, look at the 'Guidelines for Scoring/Interpretation' below to see 
where your sleep difficulty fits.  
 
For each question, please CIRCLE the (SAY WHICH choice) number that best describes your 
answer.  
 
Please rate the CURRENT (i.e., LAST 2 WEEKS) SEVERITY of your insomnia problem(s).  
Insomnia Problem 
None 
Mild 
Moderate 
Severe 
Very 
Severe 
1. Difficulty Falling Asleep 
0 
1 
2 
3 
4 
2. Difficulty Staying Asleep 
0 
1 
2 
3 
4 
3. Problems Waking up too 
early 
0 
1 
2 
3 
4 
 
4. How SATISFIED/DISSATISFIED are you with your CURRENT sleep pattern?             
 Very Satisfied       Satisfied         Moderately Satisfied      Dissatisfied   Very Dissatisfied 
           0       
   1 
                        2 
 
              3 
                 4 
 
5. How NOTICEABLE to others do you think your sleep problem is in terms of impairing the quality of 
your life? 
Not at all Noticeable       A Little           Somewhat           Much         Very Much Noticeable 
             0       
           1 
              2 
 
      3                          4 
 
 
 

 
 
 
 
6. How WORRIED/DISTRESSED are you about your current sleep problem?  
Not at all Worried         A Little             Somewhat           Much          Very Much Worried  
              0       
         1 
               2 
 
      3                        4 
 
7. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g. 
daytime fatigue, mood, ability to function at work/daily chores, concentration, memory, etc.) 
CURRENTLY?  
Not at all Interfering       A Little           Somewhat           Much        Very Much Interfering  
              0       
           1 
               2 
 
        3                          4 
 
 
Guidelines for Scoring/Interpretation:  
Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) = _______ your total score  
Total score categories: 
0–7 = No clinically significant insomnia 
8–14 = Subthreshold insomnia 
15–21 = Clinical insomnia (moderate severity) 22–28 = Clinical insomnia (severe)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Informed Consent Review [either continuation of above telephone conversation or in later call] 
Note: the Informed Consent does not have to be read word-for-word over the telephone but major points need to be reviewed, 
including:  
__ Subject Bill of Rights  
__ Background and Purpose 
__ Study Procedures/Plan 
__ Responsibilities 
__ Potential Benefits  
__ Confidentiality 
__ Participation is Voluntary 
__ Medical Treatment and Compensation  
__ Significant New Information  
__ Time Requirements 
__ Possible Risks and Discomforts 
__ Alternatives to Participate 
__ Costs and payments 
__ Right of Investigator to Withdraw Subjects  
 
Persons to Contact if Questions:  
Contact Information: Dr. Yue Leng at 415-340-2708  
 
For questions about your rights as a research participant, you can call the UCSF Institutional Review Board at 415-476-1814.  
____ Would you be interested in being screened to see if you’re eligible for this research? It will take about 30 minutes to go over 
these questions.  
____ It’s fine if you want to get back to us later about scheduling a telephone screening appointment.            ____ [If potential subject 
wants to schedule phone appointment] When would be a good day and time?  
 
 

 
 
 
 
 
Epworth Sleepiness Scale 
 
Name: 
Today’s date:   
 
 
Your age (Yrs): 
                                         Your sex (Male = M, Female = F):   
 
 
 
How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? 
 
This refers to your usual way of life in recent times. 
 
Even if you haven’t done some of these things recently try to work out how they would have affected you. 
 
Use the following scale to choose the most appropriate number for each situation: 
 
0 = would never doze 
1 = slight chance of dozing 
2 = moderate chance of dozing 
3 = high chance of dozing 
 
It is important that you answer each question as best you can. 
 
Situation 
Chance of Dozing (0-3) 
 
 
Sitting and reading 
  
 
 
Watching TV 
  
 
 
Sitting, inactive in a public place (e.g. a theatre or a meeting)   
 
 
As a passenger in a car for an hour without a break   
 
 
Lying down to rest in the afternoon when circumstances permit     
 
 
Sitting and talking to someone     
 
 
Sitting quietly after a lunch without alcohol     
 
 
In a car, while stopped for a few minutes in the traffic    
 
 
 
THANK YOU FOR YOUR COOPERATION 
© M.W. Johns 1990-97 
 

 
 
 
 
Medical Outcomes Study Questionnaire Short Form 36 Health Survey 
 
This survey asks for your views about your health. This information will help keep 
track of how you feel and how well you are able to do your usual activities. Thank 
you for completing this survey! For each of the following questions, please (say 
which choice) circle the number that best describes your answer. 
 
1. In general, would you say your health 
is: 
Excellent 
1 
Very good 
2 
Good 
3 
Fair 
4 
Poor 
5 
2. Compared to one year ago, 
Much better now than one year ago 
1 
Somewhat better now than one year ago 
2 
About the same 
3 
Somewhat worse now than one year ago 
4 
Much worse now than one year ago 
5 
 
3. The following items are about activities you might do during a typical day. Does 
your health now limit you in these activities? If so, how much? 
(Circle One Number on Each Line) 
 
Yes, 
Limited 
a 
Lot (1) 
Yes, 
Limited a 
Little 
(2) 
No, Not 
limited 
at 
All (3) 
a. Vigorous activities, such as running, lifting 
heavy objects, participating in strenuous sports 
1 
2 
3 
b. Moderate activities, such as moving a table, 
pushing a vacuum cleaner, bowling, or playing golf 
1 
2 
3 
c. Lifting or carrying groceries 
1 
2 
3 
d. Climbing several flights of stairs 
1 
2 
3 
e. Climbing one flight of stairs 
1 
2 
3 

 
 
 
f. Bending, kneeling, or stooping 
1 
2 
3 
g. Walking more than a mile 
1 
2 
3 
h. Walking several blocks 
1 
2 
3 
i. Walking one block 
1 
2 
3 
j. Bathing or dressing yourself 
1 
2 
3 
 
4. During the past 4 weeks, have you had any of the following problems with your 
work or other regular daily activities as a result of your physical health? 
(Circle One Number on Each Line) 
 
Yes 
(1) 
No 
(2) 
a. Cut down the amount of time you spent on work or other 
activities 
1 
2 
b. Accomplished less than you would like 
1 
2 
c. Were limited in the kind of work or other activities 
1 
2 
d. Had difficulty performing the work or other activities (for 
example, it took extra effort) 
1 
2 
 
5. During the past 4 weeks, have you had any of the following problems with your 
work or other regular daily activities as a result of any emotional problems (such 
as feeling depressed or anxious)? 
(Circle One Number on Each Line) 
 
Yes 
No 
a. Cut down the amount of time you spent on work or other 
activities 
1 
2 
b. Accomplished less than you would like 
1 
2 
c. Didn't do work or other activities as carefully as usual 
1 
2 
 
 
6. During the past 4 weeks, to what extent has your physical 
health or emotional problems interfered with your normal 
social activities with family, friends, neighbors, or groups? 
Not at all 
1 
Slightly 
2 
Moderately 
3 
Quite a bit 
4 
Extremely 
5 

 
 
 
7. How much bodily pain have you had during the past 4 
weeks? 
None 
1 
Very mild 
2 
Mild 
3 
Moderate 
4 
Severe 
5 
Very severe 
6 
8. During the past 4 weeks, how much did pain interfere with 
your normal work (including both work outside the home and 
housework)? 
Not at all 
1 
A little bit 
2 
Moderately 
3 
Quite a bit 
4 
Extremely 
5 
 

 
 
 
These questions are about how you feel and how things have been with you during the 
past 4 weeks. For each question, please give the one answer that comes closest to the way 
you have been feeling. (Circle One Number on Each Line) 
 
9. How much of the time during the past 4 weeks . . . 
All of 
the 
Time 
Most 
of the 
Time 
A 
Good 
Bit of 
the 
Time 
Some 
of the 
Time 
A 
Little 
of the 
Time 
None  
of the 
Time 
a. Did you feel full of pep? 
1 
2 
3 
4 
5 
6 
b. Have you been a very 
nervous person? 
1 
2 
3 
4 
5 
6 
c. Have you felt so down in 
the dumps that nothing 
could cheer you up? 
1 
2 
3 
4 
5 
6 
d. Have you felt calm and 
peaceful? 
1 
2 
3 
4 
5 
6 
e. Did you have a lot of 
energy? 
1 
2 
3 
4 
5 
6 
All of 
the 
Time 
Most 
of the 
Time 
A 
Good 
Bit of 
the 
Time 
Some 
of the 
Time 
A 
Little 
of the 
Time 
None 
of the 
Time 
f. Have you felt 
downhearted and blue? 
1 
2 
3 
4 
5 
6 
g. Did you feel worn out? 
1 
2 
3 
4 
5 
6 
h. Have you been a happy 
person? 
1 
2 
3 
4 
5 
6 
i. Did you feel tired? 
1 
2 
3 
4 
5 
6 

 
 
 
 
 
 
 
11. How TRUE or FALSE is each of the following 
statements for you. (Circle One Number on Each Line) 
 
Definitely 
True 
Mostly 
True 
Don't 
Know 
Mostly 
False 
Definitely 
False 
a. I seem to get sick a little 
easier than other people 
1 
2 
3 
4 
5 
b. I am as healthy as 
anybody I know 
1 
2 
3 
4 
5 
c. I expect my health to get 
worse 
1 
2 
3 
4 
5 
d. My health is excellent 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10. During the past 4 weeks, how much of the time has your 
physical health or emotional problems interfered with your 
social activities (like visiting with friends, relatives, etc.)? 
(Circle One Number) 
All of the time 
1 
Most of the time 
2 
Some of the time 
3 
A little of the time 
4 
None of the time 
5 

 
 
 
QUICK DEMENTIA RATING SYSTEM (QDRS) 
 
These next questions are somewhat personal and will help us understand the 
severity of your symptoms. Please find a private space.  
 
The following descriptions characterize changes in cognitive and functional 
abilities. Please compare yourself now to how you used to be—the key feature is 
change. Choose one answer for each category that best fits you.  (Note – not all 
descriptions need to be present to choose an answer.) (for each category there 
are 5 levels of severity of change) 
 
Which category best describes your:  
1. Memory and recall 
 
No obvious memory loss or inconsistent forgetfulness that does not interfere with function in 
everyday activities 
0 
Consistent mild forgetfulness or partial recollection of events that may interfere with performing 
everyday activities; repeats questions/statements, misplaces items, forgets appointments 
0.5 
Mild to moderate memory loss; more noticeable for recent events; interferes with performing 
everyday activities 
1 
Moderate to severe memory loss; only highly learned information remembered; new information 
rapidly forgotten 
2 
Severe memory loss, almost impossible to recall new information; long-term memory may be 
affected 
3 
2. Orientation 
 
Fully oriented to person, place, and time nearly all the time 
0 
Slight difficulty in keeping track of time; may forget day or date more frequently than in the past 
0.5 
Mild to moderate difficulty in keeping track of time and sequence of events; forgets month or year; 
oriented to familiar places but gets confused outside familiar areas; gets lost or wanders 
1 
Moderate to severe difficulty, usually disoriented to time and place (familiar and unfamiliar); 
frequently dwells in past 
2 
Only oriented to their name, although may recognize family members 
3 
3. Decision-making and problem-solving abilities 
 
Solves everyday problems without difficulty; handles personal business and financial matters well; 
decision-making abilities consistent with past performance 
0 
Slight impairment or takes longer to solve problems; trouble with abstract concepts; decisions still 
sound 
0.5 
Moderate difficulty with handling problems and making decisions; defers many decisions to others; 
social judgment and behavior may be slightly impaired; loss of insight 
1 
Severely impaired in handling problems, making only simple personal decisions; social judgment 
and behavior often impaired; lacks insight 
2 
Unable to make decisions or solve problems; others make nearly all decisions for patient 
3 
4. Activities outside the home 
 
Independent in function at the usual level of performance in profession, shopping, community and 
religious activities, volunteering, or social groups 
0 
Slight impairment in these activities compared with previous performance; slight change in driving 
skills; still able to handle emergency situations 
0.5 
Unable to function independently but still may attend and be engaged; appears “normal” to others; 
notable changes in driving skills; concern about ability to handle emergency situations 
1 
No pretense of independent function outside the home; appears well enough to be taken to activities 
outside the family home but generally needs to be accompanied 
2 
No independent function or activities; appear too ill to be taken to activities outside the home 
3 
 

 
 
 
 
 
 
5. Function at home and hobby activities 
 
Chores at home, hobbies and personal interests are well maintained compared with past 
performance 
0 
Slight impairment or less interest in these activities; trouble operating appliances (particularly new 
purchases) 
0.5 
Mild but definite impairment in home and hobby function; more difficult chores or tasks abandoned; 
more complicated hobbies and interests given up 
1 
Only simple chores preserved, very restricted interest in hobbies which are poorly maintained 
2 
No meaningful function in household chores or with prior hobbies 
3 
6. Toiletting and personal hygiene 
 
Fully capable of self-care (dressing, grooming, washing, bathing, toileting) 
0 
Slight changes in abilities and attention to these activities 
0.5 
Needs prompting to complete these activities but may still complete independently 
1 
Requires some assistance in dressing, hygiene, keeping of personal items; occasionally incontinent 
2 
Requires significant help with personal care and hygiene; frequent incontinence 
3 
7. Behavior and personality changes 
 
Socially appropriate behavior in public and private; no changes in personality 
0 
Questionable or very mild changes in behavior, personality, emotional control, appropriateness of 
choices 
0.5 
Mild changes in behavior or personality 
1 
Moderate behavior or personality changes, affects interactions with others; may be avoided by 
friends, neighbors, or distant relatives 
2 
Severe behavior or personality changes; making interactions with others often unpleasant or 
avoided 
3 
8. Language and communication abilities 
 
No language difficulty or occasional word searching; reads and writes as in the past 
0 
Consistent mild word finding difficulties, using descriptive terms or takes longer to get point across, 
mild problems with comprehension, decreased conversation; may affect reading and writing 
0.5 
Moderate word finding difficulty in speech, cannot name objects, marked reduction in work 
production; reduced comprehension, conversation, writing, and/or reading 
1 
Moderate to severe impairments in speech production or comprehension; has difficulty in 
communicating thoughts to others; limited ability to read or write 
2 
Severe deficits in language and communication; little to no understandable speech is produced 
3 
9. Mood 
 
No changes in mood, interest, or motivation level 
0 
Occasional sadness, depression, anxiety, nervousness, or loss of interest/motivation 
0.5 
Daily mild issues with sadness, depression, anxiety, nervousness, or loss of interest/motivation 
1 
Moderate issues with sadness, depression, anxiety, nervousness, or loss of interest/motivation 
2 
Severe issues with sadness, depression, anxiety, nervousness, or loss of interest/motivation 
3 
10. Attention and concentration 
 
Normal attention, concentration, and interaction with his or her environment and surroundings 
0 
Mild problems with attention, concentration, and interaction with environment and surroundings, may 
appear drowsy during day 
0.5 
Moderate problems with attention and concentration, may have staring spells or spend time with 
eyes closed, increased daytime sleepiness 
1 
Significant portion of the day is spend sleeping, not paying attention to environment, when having a 
conversation may say things that are illogical or not consistent with topic 
2 
Limited to no ability to pay attention to external environment or surroundings 
3 
Total QDRS score: _________ 
• 
0 to 1.5 = CDR 0 (normal) 

 
 
 
• 
2.0 to 6.0 = CDR 0.5 (MCI) -- Eligible 
• 
6.5 to 12.5 = CDR 1 (mild)-- Eligible 
• 
13.0 to 17.5 = CDR 2 (moderate) 
• 
≥18.0 = CDR 3 (severe) 
If the QDRS score is 6.5 to 12.5, they are eligible. Otherwise: 
]  
 
STOP-BANG Sleep Apnea Questionnaire 
Name _________________________________ Height ___________ Weight _________ 
Age __________ Male / Female ___________  
STOP 
 
 
Do you SNORE loudly (louder 
than talking or loud (enough to 
be heard through closed doors)?  
Yes 
No 
Do you often feel TIRED, 
fatigued, or sleepy during 
daytime? 
Yes 
No 
Has anyone OBSERVED you 
stop breathing during your 
sleep? 
Yes 
No 
Do you have or are you being 
treated for high blood 
PRESSURE? 
Yes 
No 
BANG 
 
 
BMI more than 35kg/m2? 
Yes 
No 
AGE over 50 years old? 
Yes 
No 
NECK circumference > 16 
inches (40cm)? 
Yes 
No 
GENDER: Male? 
Yes 
No 
TOTAL SCORE 
 
 
 
High risk of OSA: Yes 5 – 8 
Intermediate risk of OSA: Yes 3 - 4  
Low risk of OSA: Yes 0 - 2