Obstructive Sleep Apnea, CPAP Treatment & Cognitive Ability in HIV

NCT03478137 | Unknown

• 1 other identifier: 2017-3222
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. OSA is a condition frequently implicated in cognitive disturbances, as well as associated with health conditions such as hypertension, metabolic disturbances and heightened risk of heart disease, stroke and mortality. These conditions are 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.OSA also portends economic and societal impact through lost productivity at work and motor vehicle accidents. The presence of OSA is therefore important to detect in those living with HIV as it is potentially treatable contributors to cognitive disturbances in HIV. Continuous Positive Airway Pressure (CPAP) is the recommended treatment of choice for OSA. CPAP has established efficacy in improving cognition (executive function, long-term verbal and visual memory, attention/vigilance and global cognitive functioning). 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 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.

Conditions

Hiv; Obstructive Sleep Apnea; Cognitive Change

Keywords

Cognition; Intervention

Outcome Measures

Primary Outcomes (1)

• Changes in Cognitive Performance measure (B-CAM)

  The research team will be looking at changes on the B-CAM (brief cognitive ability measure) pre- and post-intervention

  Up to 5 months before the beginning of the intervention and up to 1 month after the end of the intervention.

Secondary Outcomes (2)

• Changes Self-reported cognitive difficulties (C3Q)

  One week before the beginning of the intervention and up to 4 weeks after the end of the intervention

• Adherence to the CPAP treatment

  During the treatment (between 4 to 7 months)

Study Arms (3)

CPAP intervention

EXPERIMENTAL

Over the course of 4-7 months, participants will have to wear the CPAP every night, at least 4 hours per night.

Behavioral: CPAP intervention

Control 1

NO INTERVENTION

Eligible participants who declined to participate in the study. Their main study visit data will be used to compare with the intervention group.

Control 2

NO INTERVENTION

Eligible participants who were not approached, hence not given the opportunity to accept or decline. Their main study visit data will be used to compare with the intervention group.

Interventions

CPAP intervention BEHAVIORAL

Participants who agree to participate 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 CPAP use at home. 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 study will end.

CPAP intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Already treated for OSA
• Ongoing involvement in night shift work
• Presence of restless legs syndrome requiring immediate specific treatment

Sponsors & Collaborators

• McGill University: lead
• VitalAire: collaborator
• ResMed: collaborator

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marie-Josée Brouillette, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Lesley K Fellows, MD/DPhil

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: March 27, 2018
• Study Start: June 5, 2017
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)