Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Cognitive Ability in HIV+ Individuals With Obstructive Sleep Apnea (OSA): A Pilot Study
Phase: NA
Conditions: Hiv, Obstructive Sleep Apnea, Cognitive Change
Sponsor: McGill University

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
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Protocol_ OSA sub-study 
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Full Title: 
 
 
 
Abbreviated title: 
 
Effect of Continuous Positive Airway Pressure (CPAP) 
treatment on cognitive ability in HIV+ individuals with 
obstructive sleep apnea (OSA): A pilot study 
 
HIV and CPAP 
 
 
 
Funding: 
The current study is sub-study of the Canadian Institute of 
Health Research (CIHR)-funded study “Understanding and 
Optimizing Brain Health in HIV Now”. 
 
CPAP devices and masks for the duration of the study are 
provided in-kind by Resmed and cost of visits related to its 
initiation and calibration are provided in-kind by VitalAire  
 
Principal Investigators: 
Dr. Marie-Josée Brouillette  & Dr. Lesley Fellows  
Glen Site-D02.4110 
Chronic Viral Illness Service 
McGill University Health Centre 
Montreal, Quebec H4A 3J1 
 
Associate investigators: 
 
 
 
 
 
 
 
 
 
 
Study design and 
statistical analyses:  
Dr Cecilia Costiniuk  
Glen Site-D02.4110 
Chronic Viral Illness Service/Division of Infectious Diseases 
McGill University Health Centre 
 
Dr Marta Kaminska 
Respiratory Division/Sleep laboratory 
1001 Decarie Blvd 
Montreal, Quebec H4A 3J1 
 
 
Dr. Nancy Mayo 
Royal Victoria Hospital, Room 4.29 
687 Pine Avenue West  
Montreal, Quebec H3A 1A1 
 
 
 
 
 
 
 
 
 

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
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Protocol_ OSA sub-study 
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PROTOCOL SUMMARY 
 
 
 
Full Title 
Effect of Continuous Positive Airway Pressure (CPAP) treatment on 
cognitive ability in HIV+ individuals with obstructive sleep apnea 
(OSA): A pilot study 
Short title 
HIV and CPAP 
Sponsor  
McGill University  
Funding 
Canadian Institute of Health Research (CIHR)  
CPAP and masks for the duration of the study are provided in-kind 
by Resmed and cost of visits related to its initiation and calibration 
are provided in-kind by VitalAire  
Principal 
Investigators 
Dr. Marie-Josée Brouillette, Dr. Lesley Fellows, Dr. Nancy Mayo  
Associate 
investigators 
Dr. Cecilia Costiniuk, Dr. Marta Kaminska 
 
Objectives 
 
 
 
The primary objective is to estimate among people with HIV and 
obstructive sleep apnea, the extent to which 4-7 months of CPAP 
impacts on the primary outcome of cognitive ability (B-CAM), in 
comparison to individuals who screen positive for OSA but are not 
participating in the sleep apnea intervention. 
An exploratory objective is to identify whether the changes are 
similar on measured cognitive ability and on self-reported cognitive 
symptoms.   
The explanatory objective is to relate degree of adherence to CPAP 
to change in cognitive outcomes.  
Study Population 
Inclusion Criteria 
 Participants in the cohort study “Understanding and 
Optimizing Brain Health in HIV Now” 
 Screened positive for OSA using the Berlin or the STOP-
BANG (completed as part of the main study visits) 
 Have been on a stable HAART regimen for > 6 months 
 B-CAM ≤ 29 
 Have not had a change in medications that could potentially 
interfere with sleep or cognition in the past 4 months. 
 Willing to use CPAP as per instructions  
 Able to comply with follow-up visit assessments 
 Able to communicate in English or French 
 Have at least one remaining visit in the main cohort study 
Exclusion Criteria 
 Already treated for OSA 

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 Ongoing involvement in night shift work 
 Presence of restless legs syndrome requiring immediate 
specific treatment 
Study Design 
Quasi-experimental single-arm, pre-post design will be carried out 
over a period of 4-7 months.  
Sample Size 
30 participants have used the CPAP device for a minimum of 4 
months, on at least 30% of the nights with a median use of ≥ 4 
hours/night. 
Participant 
involvement 
Up to 12 months  
 
 
 
 

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BACKGROUND  
Cognition and HIV: People living with HIV worry about their memory, and with good 
reason. As their life expectancy increases, it is becoming clear that this chronic illness 
affects cognition, even with excellent systemic viral control. The cognitive disturbances 
observed in HIV infection fall under the broader term HIV-associated neurocognitive 
disorders (HAND). Although the prevalence of HAND in Canada is unknown, it is likely 
to be high. Recent studies in other developed countries report a prevalence of cognitive 
impairment of 30-50% [1, 2]. Even higher rates have been documented in those over the 
age of 50, a rapidly expanding group.  
There is currently no treatment for HAND. However, it is now recognized that HIV 
infection is associated with several medical conditions that independently contribute to 
cognitive disturbances. Identification and treatment of potentially reversible contributors 
to cognitive impairment is therefore key to the clinical management of these cognitive 
difficulties.    
Definition of obstructive sleep apnea: Obstructive sleep apnea (OSA) is a breathing 
disorder that is characterized by episodes of complete or partial cessation of respiration 
during sleep, associated with upper airway collapse, oxygen desaturation and sleep 
fragmentation [3] . The index commonly used to assess sleep disordered breathing (SDB) 
is the respiratory disturbance index (RDI), defined as the average number of respiratory 
disturbances (obstructive apneas, hypopneas, and respiratory event–related arousals 
[RERAs]) per hour. According to the Centers for Medicare & Medicaid Services criteria 
for the positive diagnosis and treatment of obstructive sleep apnea, a positive test for 
OSA is established if the RDI ≥ 15 events per hour [4].   
Obstructive sleep apnea and cognition: Obstructive sleep apnea (OSA) is a condition 
frequently implicated in cognitive disturbances   [3, 5-10]. These cognitive deficits are 
common : for example, in a meta-analysis of individuals with OSA, information 
processing speed was reduced in as many as 75% of individuals compared with norm-
referenced data [6].  In addition to its negative impact on cognition,  OSA is associated 
with health conditions such as hypertension, metabolic disturbances (including impaired 
glucose tolerance, insulin resistance and dyslipidemia) and heightening risk of heart 
disease, stroke and mortality [11-13], conditions also increased in persons living with 
HIV. Individuals suffering from OSA report an increase in daytime sleepiness, mood 
changes and decline in quality of life [6-10]. OSA also portends economic and societal 
impact through lost productivity at work and motor vehicle accidents [14].The presence 
of OSA is therefore important to detect in those living with HIV as it is a potentially 
treatable contributors to cognitive disturbances in HIV. 
Obstructive sleep apnea and HIV: General population estimates of moderate to severe 
sleep-disordered breathing depend on criteria used and vary widely [15], from 6-13% of 
individuals [6, 16], to up to 23% of women and 50% of men [17] using modern criteria. 
This prevalence is increased in the HIV population. Based on data from the Multicenter 
AIDS Cohort Study (MACS, N=1896) and Women’s Interagency HIV Study (WIHS, 
N=1976), HIV-infected individuals are more likely to be diagnosed with OSA than HIV-
uninfected individuals when confounders such as age and body mass index were 
accounted for (Prevalence Ratio (PR) 1.42; p=0.01 and PR 2.10; p=0.002, respectively) 

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[18]. HIV-infected individuals have many risk factors for OSA including a high rate of 
obesity: >60% of HIV-infected women in the WIHS and >40% of HIV-infected men and 
MACS [19].  
Traditional risk factors associated with OSA include advanced age, male gender, large 
neck circumference, obesity and hypertension [13]. However, these traditional clinical 
indicators of OSA may be less salient in the presence of HIV infection. In a large 
observational study, those with HIV and OSA were more likely to be younger, have 
lower body-mass-indexes and were less likely to have hypertension than those without 
HIV infection [20].  As a result of this different risk profile, the presence of OSA in 
HIV+ individuals was more often undiagnosed [20], underscoring the need for a higher 
index of suspicion in the presence of HIV infection.  
Treatment of obstructive sleep apnea and its impact on cognition: Continuous Positive 
Airway Pressure (CPAP) is the recommended treatment of choice for OSA.  A CPAP 
device includes a pump which delivers air via a mask covering the nose or mouth while a 
person in sleeping [21]. The flow of air generates positive pressure, which opens the 
airways, preventing soft tissue collapse [21].  
CPAP has established efficacy in improving cognition. A meta-review involving review 
articles meeting pre-determined strict criteria, concluded that CPAP use improved 
executive function, long-term verbal and visual memory, attention/vigilance and global 
cognitive functioning [22]. Another meta-analysis also found that individuals with OSA 
demonstrated medium to very large impairments executive dysfunction, independent of 
age and disease severity, which showed small to moderate improvements following 
CPAP treatment [23]. In the context of Alzheimer’s disease, Ancoli-Israel et al. 
conducted a randomized double-blind placebo-controlled trial to determine whether 
CPAP use resulted in improvements in neuropsychological test scores.  Although the 
study was underpowered to make definitive conclusions about improvements within 
specific cognitive constructs, exploratory post hoc examination of score changes 
suggested that CPAP use by individuals with OSA yielded some benefits; these included 
improvements in episodic verbal learning and memory and some aspects of executive 
functioning such as cognitive flexibility and mental processing speed [24].  
Although CPAP has been associated with improvements in cognitive functioning in the 
general population, its effectiveness in improving cognition in HIV+ individuals has 
never been previously tested.  Given that the cognitive disturbances in this population are 
multi-factorial, determining whether treatment of OSA in this population improves 
cognition is key in improving the clinical management of HIV+ individuals, both for its 
negative impact on cognition but also more generally for their health. 
Obstructive sleep apnea in the cohort “Understanding and Optimizing Brain Health 
Now”. Cohort participants (N=840) are studied prospectively over a 27-month period 
with visits every 9 months.  Patients complete a computer-based evaluation of cognitive 
ability, the B-CAM, as well as questionnaires on socio-demographic characteristics, 
symptom status, functional status, health perception and quality of life.  Given the high 
prevalence of OSA reported in the population, participants complete questions that, 
combined with other values already documented, support the scoring of two screening 
questionnaires for OSA, the Berlin [25, 26]  and the STOP-BANG [27, 28] (see 

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Appendix 1). Selected cohort members at the Montreal sites who screen positive for the 
presence of OSA will be invited to participate in the study. 
STUDY OBJECTIVES 
The overall aim is to contribute evidence about the impact of treatment of sleep apnea 
(with CPAP) on cognitive ability in HIV+ individuals.  
The primary objective is to estimate among people with HIV and obstructive sleep apnea, 
the extent to which 4-7 months of CPAP impacts on cognitive ability (B-CAM), in 
comparison to individuals who screen positive for OSA but are not participating in the 
sleep apnea intervention. 
An exploratory objective is to identify whether the changes are similar on measured 
cognitive ability and on self-reported cognitive symptoms.   
The explanatory objective is to relate degree of adherence to CPAP to change in 
cognitive outcomes. 
STUDY HYPOTHESIS 
Given there is no expectation for improvement in cognitive ability in this population in 
the absence of treatment for sleep apnea, we hypothesize that, over 4-7 months weeks of 
CPAP use, an improvement in cognition will occur, and if this is observed in 7 or more of 
30 people, this response frequency is unlikely to have occurred by chance.  
STUDY DESIGN 
This study is part of a larger project based upon a cohort multiple randomized controlled 
design [29]. Within a fully characterized cohort (N=840) which is followed over time, 
people meeting the specific criteria for one or more interventions (here CPAP) are 
identified and a sample is randomly selected to receive the intervention; the remaining 
eligible persons who do not receive the intervention serve as controls. This design, when 
operationalized for one intervention, yields three cohorts: (i) the intervention cohort 
comprising all those approached who agreed to enter; (ii) the refuser cohort comprising 
all those approached who declined entry; and (iii) control cohort comprising eligible 
persons who were not approached, and hence were not given the opportunity to accept or 
decline.  For the CPAP intervention, the duration of the study is 4-7 months.  
Eligible patients will be identified among the Montreal participants (N=500) in the 
“Understanding and Optimizing Brain Health Now” cohort study who have screened 
positive for the possible presence of sleep apnea on either the Berlin or the STOP-BANG 
and experience some cognitive difficulties as measured by the B-CAM (≤ 29). We will 
continue recruitment until 30 participants have used the CPAP device for a minimum of 4 
months, on at least 30% of the nights with a median of ≥ 4 hours/night.  
Eligibility criteria 
Inclusion criteria 
 Participants in the cohort study “Understanding and Optimizing Brain Health in 
HIV Now” 

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 Screen positive for the presence of OSA with either the Berlin or the STOP-
BANG 
 Have been on a stable HAART regimen for > 6 months 
 B-CAM score ≤ 29 
 Have not had a change in medications that could potentially interfere with sleep or 
cognition in the past 4 months. 
 Willing to use CPAP as per instructions  
 Able to comply with follow-up visit assessments 
 Able to communicate in English or French 
 Have at least one remaining visit in the main cohort study 
Exclusion criteria 
 Already treated for OSA 
 Ongoing involvement in night shift work 
 Presence of restless legs syndrome requiring immediate specific treatment  
 
Screening: 
Brain Health Now study participants who screen positive for the presence of OSA, meet 
inclusion/exclusion criteria based on the information already available as part of the main 
study questionnaires and who, on initial enrolment, have agreed to be contacted for sub-
studies, will be approached for participation. Those who agree to participate and provide 
informed consent will be referred for a polysomnography (sleep study). Those with 
confirmed OSA will continue to the intervention phase. 
Intervention (CPAP) 
Participants will be evaluated by a sleep specialist who will confirm eligibility for CPAP 
treatment. Eligible participants will be referred to VitalAire for initiation of treatment, 
following a standard protocol for use in the home (see Appendix 2). CPAP treatment will 
continue until the next visit for the main study, between 4-7 months based on the timing 
of the evaluations, after which the OSA study will end. 
Post Intervention 
At the end of the study, participants will be referred to the sleep clinic where the sleep 
nurse will facilitate obtaining a device as per usual clinical care (private insurance, self-
funded, welfare, second hand, etc). Participants who opt to buy the CPAP machine that 
they have been using will have a 20% discount. There may be a gap between the end of 
the study and allocation of a new device; this fact is mentioned in the informed consent 
document. All participants will be able to keep their mask.  
Measurement  
Four types of measures are under study: (i) cognitive ability; (ii) self-reported cognitive 
symptoms; (iii) adherence to the CPAP treatment; and (iv) cohort.   
(i) 
Cognitive ability will be measured using the B-CAM which comprises 
computerized cognitive tests and yields a score on a continuous metric [30].  

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The values to be used will be those collected during the scheduled platform 
evaluations which occur 9-12 months apart.    
(ii) 
Self-reported cognitive symptoms will be measured using the C3Q 
(Communicating Cognitive Concerns in HIV) collected during the scheduled 
platform evaluations which occur 9-12 months apart.    
(iii) 
Adherence to the CPAP home treatment will be obtained from the CPAP 
device directly through its telemonitoring function, which is done by 
activating modems on CPAP machines and having the data transferred onto 
the Compliance Management Solutions. The granularity of the data will yield 
a continuous metric of sleep-minutes of use. Reasons for poor adherence and 
tolerance will be obtained by telephone contact or at clinical visits with the 
sleep specialist. 
(iv) 
Three cohorts will be compared: (i) the intervention cohort comprising all 
those approached who agreed to enter; (ii) the refuser cohort comprising all 
those approached who declined entry; and (iii) control cohort comprising 
eligible persons who were not approached, and hence were not given the 
opportunity to accept or decline.   
Procedures 
Patients diagnosed with OSA will be referred to VitalAire, a company that has agreed to 
loan Resmed CPAP devices, free-of-charge, to participants in this study (Appendix 3: 
Confirmation of collaboration).  Staffs at VitalAire are under legal obligation to protect 
the confidentiality of information. Procedures for use of the devices will be explained to 
the patients. Follow-up with VitalAire staff will be done according to standard clinical 
protocols (see attached, Appendix 2). Patients may have as many visits with the 
respiratory therapist of VitalAire as needed for adjustments to their devices, at no cost. 
Typically patients will be contact by telephone one week after initiation and have follow-
up in person with VitalAire after 1 month of CPAP use, but this may vary according to 
needs and availability.  
During the course of CPAP use, the device automatically monitors various parameters 
which are used to monitor compliance in addition to residual apnea/hypopnea index 
(AHI) to ensure the settings are optimal. These data are obtained on line via the 
telemonitoring function and communicated by VitalAire to the study team. A separate 
consent will be signed at the same time as the consent for the OSA study, giving staff at 
VitalAire permission to communicate information to the study team (see Appendix  4). 
As part of routine clinical care, patients will have a follow-up with a sleep specialist three 
months into the initiation of their CPAP to verify their clinical status and troubleshoot 
any issues with CPAP use. Additional visits will be scheduled if needed. A visit will also 
occur at the end of the study to plan post-study treatment.  
Statistical Analysis and Sample 
Basic descriptive statistics will be used to characterize the participants including values 
on the all outcomes.  Each person will be classified as a cognitive responder or not based 
on change on B-CAM.  Responder status will be defined as improvement of ½ SD in B-

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CAM score and C3Q.  The analysis will focus on estimating the proportion of responders.  
A sample size of 30 participants will provide sufficient power for within-group analysis. 
With the assumption that the outcome is drawn from a binomial distribution with an 
expected probability of response of 10% (N=3) with no intervention, 30 subjects in the 
intervention group will allow detection of a positive response, with 80% power and 
p<0.05, if 7 or more persons respond (stattrek.com binomial calculator.)  The proportion 
of responders on the different cognitive outcomes will also be estimated.   
A secondary analysis will relate adherence to CPAP to change in cognitive outcomes 
using linear regression adjusting for age, sex, weight, baseline sleep satisfaction.  
For between-cohort comparisons of cognitive outcomes, generalized estimating equations 
(GEE) will be used to permit both the baseline and post-intervention measures to be 
included along with the within-person correlation.  A linear GEE will be used as the 
outcomes are continuous although a binary response was used for the primary objective.  
The model will include the indicator variable for cohort (CPAP, refuser, or control), time 
(assessment 1, 2), as well as confounding variables of age, sex, education, BMI, and co-
morbidity. As the control cohort will be very much larger than the intervention cohort, 
statistical comparisons have sufficient power to detect effect sizes of 0.5 or greater, 
suitable for a pilot study.  The parameter estimated from GEE is equivalent to an adjusted 
effect size (adjusted between cohort effect divided by correlation adjusted standard error).   
Potential Risks and Benefits  
CPAP is the standard of care treatment for sleep apnea; what is under study here is its 
impact on cognition in HIV+ individuals. Possible side effects of CPAP or problems 
related to sleeping with a mask may include a transient sensation of difficulty breathing, 
bloating and gas in the morning, headaches or sores on the nose due to improperly 
adjusted mask, skin allergy to the mask, runny nose, dry or irritated eyes and dry mouth. 
These are usually minor and reversible. Assessment and troubleshooting is also routinely 
done automatically by staff at VitalAire and by the sleep specialist at the follow-up visits. 
CPAP therapy may need to be discontinued if side effects are intolerable despite best 
efforts to correct them (this occurs very rarely). 
No reimbursement is provided for visits. Benefits include prompt access to 
polysomnography (for which there is a wait that can be as long as one year when done in 
hospital), free access to a CPAP device and close monitoring for the duration of the study 
for 4-7 months. After the end of the study, patients will have usual clinical follow-up in 
the MUHC sleep clinic, including discussion with the sleep nurse regarding available 
resources for obtaining a CPAP device-but we cannot ensure that there will not be a gap 
between the end of the study and the availability of a suitable CPAP device. A discount 
of 20% will be provided at VitalAire for participants who opt to but their device. All 
participants will be able to keep their study mask. 
Anticipated results, clinical significance and next steps 
We anticipate that this pilot study will demonstrate that a research study involving CPAP 
use is warranted and feasible in HIV-infected patients with OSA as judged by proportion 
of response and adherence. We also expect to find improvements in cognitive ability and 
cognitive symptoms following CPAP implementation. The findings from this pilot study 

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will inform a larger, more comprehensive study into the use of CPAP as a tool to improve 
neurocognitive outcomes in HIV+ individuals. Understanding whether cognition in 
persons living with HIV and OSA can be improved through the use of CPAP is important 
since this is a potentially modifiable risk factor with implications at both the individual 
and societal levels. 
 
ETHICS/ PROTECTION OF HUMAN SUBJECTS 
Informed consent 
 
All subjects will be given detailed oral and written information about the study. Consent 
forms describing in detail the study procedures, anticipated benefits and potential risks 
will be given to each participant and written documentation of informed consent is 
required prior to starting the study. Each subject should have sufficient opportunity to 
discuss the study and consider the information in the consent process prior to agreeing to 
participate. Subjects may withdraw consent at any time during the course of the trial. The 
original signed informed consent form will be retained in the subject’s study files and a 
copy will be provided to the subject.  Participants will also be asked to sign a consent 
giving permission to VitalAire permission to communicate information to the study staff; 
that consent will be sent to VitalAire.      
Participant Confidentiality 
As the CPAP treatment is clinically indicated, nominal information will be 
communicated to VitalAire in order to allow ongoing communication with the participant 
and the respirologist overseeing treatment. All research records will be kept in a secure, 
locked location and only research staff will have access to the records. Upon request, 
clinical information may be reviewed by or released to auditors, CIHR or regulatory 
agencies.  For participants who are invited to participate but refuse, the positive screen 
for the presence of OSA will be communicated to their treating physician as a “red flag” 
of potential significance for clinical care. The communication of such pertinent medical 
information was already included in the informed consent for the Brain Health Now 
study.   
Record Retention 
Data and study documents at all sites will be stored securely for 7 years, after which they 
will be destroyed in keeping with the privacy and confidentiality regulations and 
guidelines.  
 
 

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Ahmadi, N., et al., The Berlin questionnaire for sleep apnea in a sleep clinic 
population: relationship to polysomnographic measurement of respiratory 
disturbance. Sleep Breath, 2008. 12(1): p. 39-45. 
27. 
Chung, F., H.R. Abdullah, and P. Liao, STOP-Bang Questionnaire: A Practical 
Approach to Screen for Obstructive Sleep Apnea. Chest, 2016. 149(3): p. 631-8. 
28. 
Chung, F., et al., Validation of the Berlin questionnaire and American Society of 
Anesthesiologists checklist as screening tools for obstructive sleep apnea in 
surgical patients. Anesthesiology, 2008. 108(5): p. 822-30. 
29. 
Mayo, N.E., M.J. Brouillette, and L.K. Fellows, Understanding and optimizing 
brain health in HIV now: protocol for a longitudinal cohort study with multiple 
randomized controlled trials. BMC Neurol, 2016. 16: p. 8. 
30. 
Brouillette, M.J., et al., Quantifying cognition at the bedside: a novel approach 
combining cognitive symptoms and signs in HIV. BMC Neurol, 2015. 15(1): p. 
224. 
 
 

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
13 
Protocol_ OSA sub-study 
V1-Final, January 23, 2017 
Appendix 1. Questionnaires screening for the presence of OSA administered as part of 
the main study 
 
MERGED BERLIN AND STOP BANG QUESTIONNAIRE (FOR SLEEP APNEA) 
 
 
1. Do you snore? 
a. Yes 
b. No 
 
2. If answer is yes, your snoring is: 
a. Slightly louder than breathing  
b. As loud as talking  
c. Louder than talking  
d. Very loud – loud enough to be heard through closed doors or your bed-
partner elbows you for snoring at night? 
 
3. How often do you snore? 
a. Nearly every day  
b. 3-4 times a week  
c. 1-2 times a week  
d. 1-2 times a month  
e. Never or nearly never 
 
4. Has your snoring ever bothered other people?  
a. 
Yes  
b. 
No  
c. 
Don’t Know 
 
5. Has anyone observed you Stop Breathing or Choking/Gasping during your sleep? 
a. 
Yes  
b. No 
 
       5.1 If people have noticed that you quit breathing during your sleep, how often does 
that happen? 
a. 
Nearly every day  
b. 
3-4 times a week  
c. 
1-2 times a week  
d. 
1-2 times a month  
e. 
Never or nearly never 
 
6. How often do you feel tired or fatigued after your sleep?  
a. Nearly every day  
b. 3-4 times a week  
c. 1-2 times a week  
d. 1-2 times a month  

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
14 
Protocol_ OSA sub-study 
V1-Final, January 23, 2017 
e. Never or nearly never 
 
7. Do you often feel Tired, Fatigued, or Sleepy during the daytime? 
a. 
Yes 
b. 
No 
 
7.1 If yes, how often do you feel Tired, Fatigued, or Sleepy during the daytime? 
a. Nearly every day  
b. 3-4 times a week  
c. 1-2 times a week  
d. 1-2 times a month  
e. Never or nearly never 
 
8. Have you ever nodded off or fallen asleep while driving a vehicle? 
a. Yes 
b. No 
 
        
 
 
 
 
 

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
15 
Protocol_ OSA sub-study 
V1-Final, January 23, 2017 
Appendix 2: Standard protocol for initiation of CPAP in the home 
 
See attached: Contact Management Schedule and Compliance with Telemonitoring 
 
 
 

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
16 
Protocol_ OSA sub-study 
V1-Final, January 23, 2017 
 Appendix 3: confirmation of collaboration 
 
From: Perraud, Cecile [Cecile.Perraud@airliquide.com] 
Sent: September 15, 2015 11:26 PM 
To: Marta Kaminska, Dr; marie-josee.brouillette@muhc.mcgill.ca; 
Cecilia.Costiniuk@muhc.mcgill.ca 
Cc: Normandeau, Guy 
Subject: RE: Etude VIH - apnee 
Bonjour, 
 Avant tout, nous vous remercions de nous proposer de nous associer au projet. 
 Nous avons contacté les fournisseurs pour recevoir leur offre de fournitures. 
Parallèlement et dans l’attente d’un courrier officiel que je vous soumettrais, vous pouvez 
d’ores et déjà compter sur le support de Vitalaire sur le volet initiation a la 
thérapie/formation/suivi. 
 Très sincèrement. 
  
Cécile Perraud 
Directrice Régionale 
  
7100, rue Jean Talon Est - Bureau 100 
H1M 3S3 MONTREAL-ANJOU, QC 
Tel: (514) 728 2664 # 6021 - Mobile: (514) 378 7175 
cecile.perraud@airliquide.com 
www.VitalAire.com 
  
  
 
From: PERRAUD, Cecile [Cecile.Perraud@airliquide.com] 
Sent: October 13, 2015 2:17 PM 
To: Marta Kaminska, Dr; marie-josee.brouillette@muhc.mcgill.ca; 
Cecilia.Costiniuk@muhc.mcgill.ca 
Cc: NORMANDEAU, Guy 
Subject: RE: Etude VIH - apnee 
Bonjour, 
 Je vous reviens suite à nos rencontres avec les fournisseurs. 
Le fournisseur Respironics serait intéressé mais doit soumettre le projet a un comite de 
sélection. Le processus de retour est de 12 semaines. 
Le fournisseur Resmed est également intéressé et disponible pour approvisionner les 
équipements (masques et unités) selon notre demande. Si vous êtes d’accord, je vous propose 
d’aller de l’avant avec les produits Resmed, qui offrent toutes les fonctionnalités demandées 
pour votre projet. Nous pourrions organiser une démonstration de l’outil et ensuite bâtir le 
protocole de suivi avec vous. 
Dans l’attente de votre retour, 
Très sincèrement, 
  
 Cécile Perraud 
Directrice Régionale 
 
From: Marta Kaminska, Dr [mailto:marta.kaminska@mcgill.ca]  
Sent: Tuesday, October 13, 2015 3:30 PM 

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
17 
Protocol_ OSA sub-study 
V1-Final, January 23, 2017 
To: PERRAUD, Cecile; marie-josee.brouillette@muhc.mcgill.ca; Cecilia.Costiniuk@muhc.mcgill.ca 
Cc: NORMANDEAU, Guy 
Subject: RE: Etude VIH - apnee 
  
Merci pour le suivi.  
Quand a moi je suis d'accord pour y aller avec Resmed. 
Pour le protocol de suivi, il serait probablement concordant avec le protocol habituel clinique de 
VitalAire. Pourriez-vous nous en envoyer une copie? Nous pourrions ensuite voir s'il y a lieu d'y 
porter des modifications pour l'etude. 
Salutations, 
 Marta Kaminska MD, M.Sc. FRCP(C) 
McGill University Health Centre 
Respiratory Division / Sleep laboratory 
1001 Decarie Blvd, Montreal, Qc, Canada 
H4A 3J1 
tel: 514-934-1934 ext 35650/36117 
fax: 514-843-1695 
marta.kaminska@mcgill.ca 
 
 
"NORMANDEAU, Guy" 
<Guy.Normandeau@airliquide.com>  
04/12/2016 05:11 PM 
To
"marie-josee.brouillette@muhc.mcgill.ca" <marie-
josee.brouillette@muhc.mcgill.ca> 
cc  
Sub
ject
Rabais CPAP - Projet VIH 
 
Après avoir revérifier toutes nos ententes  je suis heureux de t’informer que les patients que 
nous accueillerons dans le cadre du projet de recherche sur le VIH pourront jouir d’un rabais de 
20% sur l’appareil CPAP au moment de l’achat. 
Excuse ma lenteur dans ce dossier. 
Cordialement, 
  
Guy Normandeau 
Chef de secteur/Area Manager – Quebec 
 
 

Effect of Continuous Positive Airway Pressure (CPAP) treatment on cognitive 
ability in HIV+ individuals with obstructive sleep apnea (OSA): A pilot study 
 
 
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Protocol_ OSA sub-study 
V1-Final, January 23, 2017 
 
 Appendix 4: VitalAire consent to collect and communicate information 
 See attached