Clinical trial NCT04323254: Language of Sleepiness
Official title: The Language of Sleepiness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep
Sleep Disorder
Sleepiness
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
First posted: 2020-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients new to the UCSD Pulmonary and Sleep Clinic with no prior sleep consultations.

Brief summary: Subjects will complete an electronic consent form and then fill out questionnaires on a tablet computer. The answers to the questions will be recorded to a secure electronic database, along with the results of a clinical overnight sleep study performed separately from this research study (this research study will not perform any overnight visits). After the overnight study diagnosis researchers will see which answers are most commonly given in association with each diagnosis. In addition, we will assess to what extent the sleep disorder impacts the patient's perception of his/her quality of life.

Detailed description: Research questionnaires will be given along with the clinical intake form to all patients who are interested in participating in our study. Subjects will complete an electronic consent form and then proceed to questionnaires on a tablet computer (outlined below). The answers to the questions will be recorded to a secure electronic database, REDCap, along with the results of the overnight sleep study (when available). For the initial analysis, we will determine the sleep diagnosis and see which descriptors are most commonly used in association with each diagnosis. In addition, we will assess to what extent the sleep disorder impacts the patient's perception of his/her quality of life. These analyses will be simple correlations for the linear scales and unpaired t-tests to compare different diagnoses.

REDCap REDCap, is a password-protected secure web application that we will use to build and manage our study database. REDCap is a HIPAA-compliant environment. Subjects will have a coded study identifier associated with their research documents and questionnaires. Only key personnel on this study will have access to the study database.

Questionnaires:

* Work Productivity Impairement Questionnaire-The questionnaire assesses how much sleepiness has impacted the subject's ability to work.
* Language of Sleepiness Questionniare-The questionnaire will capture what descriptors those with sleep issues use prior to their sleep consulation.
* San Diego Wisdom Scale (SD-WISE) - The questionnaire assesses subject's wisdom scores.
* Functional Outcomes of Sleep Questionnaire - The questionnaire is a subjective measure of sleepiness and quality of life.
* Beck Depression Index II - The questionnaire assesses mental health (i.e. depression).

Study Visit Patients that elect to participate in the study will be consented in either the sleep clinic conference room or sleep clinic exam room. Subjects will then complete the questionnaires on a tablet. The research documents and questionnaires will be hosted on REDCap, a secure electronic database. For participants who are not comfortable with the electronic format, we will provide paper copies of the questionnaires and enter their data manually into REDCap.

The total study time is estimated to be \<20 minutes, which includes the consent process. Administration of the questionnaires should take 5-7 minutes. These activities will be completed before the subject's sleep consultation.

After Study Visit:

We will access subjects' medical records to document their vitals, age, race/ethnicity, height, weight, date of birth, phone number, medications, medical and surgical history, alcohol history, illicit drug including cannabidiol, allergies, and Epworth Sleepiness Scale (ESS) value from the day of their study visit (i.e. first sleep consultation appointment). We will also collect data from their sleep study. If the subject completes a Home Sleep Test the following will be obtained: time to bed, wake time, apnea hypopnea index (AHI), apnea index (AI), hypopnea index (HI), obstructive apnea index (OAI), central apnea index (CAI), mixed apnea index (MAI), Cheyne - Stokes respiration, oxygen desaturation index (ODI), oxygen saturation, # of breaths, and pulse.

Eligibility criteria: Inclusion Criteria:

1. Total participants: 200 (UCSD only)
2. Ages: 18 - 89
3. Gender: Men and Women
4. Ethnic background: All

We will not recruit vulnerable patient groups.

Exclusion Criteria:

1. Prior Sleep consultation
2. Prisoners
3. Cognitive impairment, unable to provide consent, or unable to carry out research procedures

Primary outcomes:
measure: Language of Sleepiness Questionniare
timeFrame: 5 minutes
Secondary outcomes:
measure: Work Productivity Impairement Questionnaire
timeFrame: 5 minutes
measure: San Diego Wisdom Scale (SD-WISE)
timeFrame: 5 minutes
measure: Functional Outcomes of Sleep Questionnaire
timeFrame: 5 minutes
measure: Beck Depression Index II
timeFrame: 5 minutes
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Health - Pulmonary and Sleep Clinic
state: California
city: San Diego
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
Study officials:
affiliation: Faculty
name: Bernie Sunwoo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.
citation: Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
citation: Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015 Apr;3(4):310-8. doi: 10.1016/S2213-2600(15)00043-0. Epub 2015 Feb 12.
citation: Hirsch Allen AJM, Bansback N, Ayas NT. The effect of OSA on work disability and work-related injuries. Chest. 2015 May;147(5):1422-1428. doi: 10.1378/chest.14-1949.
citation: Weaver TE, Maislin G, Dinges DF, Bloxham T, George CF, Greenberg H, Kader G, Mahowald M, Younger J, Pack AI. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007 Jun;30(6):711-9. doi: 10.1093/sleep/30.6.711.
citation: Daurat A, Ricarrere M, Tiberge M. Decision making is affected in obstructive sleep apnoea syndrome. J Neuropsychol. 2013 Mar;7(1):139-44. doi: 10.1111/j.1748-6653.2012.02039.x. Epub 2012 Oct 23.