Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06620601

Conditions

Sleep Apnea

Sleep Disorder

Sleep Deprivation

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Portable Polysomnography

Treatment

Questionnaires

Study Details

Brief summary:

In Canada, 35,000 people are experiencing homelessness on any night. Compared to the general population, people experiencing homelessness (PEH) sleep less and experience increased daytime fatigue. A common sleep disorder and treatable cause of morbidity and low quality of life is sleep apnea. High prevalence of chronic comorbid disorders of sleep apnea in PEH suggest high prevalence of sleep apnea, but the rate of sleep apnea treatment in PEH is very low. Also, in PEH, individual and systemic barriers lead to a high rate of underdiagnosed and untreated sleep apnea. Mortality is higher in PEH than the general population, and sleep apnea remains a potential silent cause of morbidity and low quality of life in PEH. Our goal is to diagnose and treat sleep apnea in people living in shelters and to examine the effect of patient-centered treatment on their quality of life.

Conditions

Sleep Apnea

Sleep Disorder

Sleep Deprivation

Sleep Disturbance

Study ID

NCT06620601

Start date

Oct 20, 2021

Status verified date

Sep, 2024

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Residing in a shelter at the time of recruitment
  • Age >18 years old

Exclusion Criteria:

  • Allergies to medical tape \[for diagnosis study\].
  • Requiring extensive dental treatment or periodontal disease with tooth mobility \[for treatment study\].

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnosis

Description:

A portable polysomnography device to assess sleep apnea in individuals at risk of sleep apnea. The Prodigy 2 has Health Canada Approval for home sleep study. The system is small, easy to use, and can be setup by a research technician at the shelter. Prodigy measures thoraco-abdominal motion, nasal airflow, oxyhemoglobin saturation (SpO2), cardiac function with electrocardiogram and leg movement. The main advantage of Prodigy 2 to other portable devices is that it has a simple headband to record forehead electroencephalogram to detect rapid eye movement (REM) and non-REM sleep stages. After processing Prodigy 2 signals, an apnea-hypopnea index (AHI) will be calculated for each participant based on the number of respiratory events (apneas or hypopneas) per hour of sleep. The investigators will measure AHI, REM AHI, non-REM AHI, AHI in different body postures, snoring duration, arousal index, sleep time with SpO2<90%, oxygen desaturation index (ODI), and sleep efficiency.

experimental: Treatment

Description:

Individuals who are diagnosed with sleep apnea, and are deemed eligible for treatment, will receive a treatment option based on Canadian Agency for Drugs and Technologies in Health (CADTH), physician recommendations, and the participant's preferences. In this study, auto-titrating positive airway pressure (Auto-CPAP) and Mandibular advancement device (MAD) will be the main modalities of treatment.

other: Screening

Also, the participants are asked to complete the following questionnaires with the help of a research assistant. The result of the application will be combined with the questionnaires for the final risk assessment.

  • Participant Demographics questionnaire
  • STOP-Bang
  • Insomnia severity index
  • Epworth sleepiness score (ESS)
  • Functional outcome of Sleep Questionnaire (FOSQ-10)
  • Beck Depression Inventory (BDI)
  • Chalder Fatigue Scale (CFQ)
  • Health Information Technology Usability Evaluation Scale (Health-ITUES) Questionnaire
  • Oral Health Impact Profile - 14 (OHIP-14)
  • Asthma Control Test (ACT)
  • Primary care post-traumatic stress disorder (PTSD) screen (PC-PTSD-5)
  • A survey to help identify barriers to treatment in the people experiencing homelessness (General Survey)

Interventions

Portable Polysomnography

Research assistants set up the portable polysomnography (Prodigy) for the overnight sleep study.

Treatment

Based on the decision aid, patient preference, and CADTH recommendations, the sleep physicians will recommend the participant to use Auto-CPAP or MAD for six months.

Questionnaires

Participants will complete eleven questionnaires: Stop-Bang, Insomnia severity index, Epworth sleepiness score (ESS), quality of life (FOSQ-10), Beck Depression Inventory (BDI), Chalder Fatigue Scale (CFQ), primary care post-traumatic stress disorder (PTSD) scale (PC-PTSD-5), Asthma control questionnaire (ACQ), OHIP-14, and Participant demographics. The RA will help the participants complete the questionnaires (\~one and a half hours in total).

Primary outcome measure

  • To assess the prevalence of sleep apnea in shelter residents. [ Time Frame: up to 4 years. ]
  • Changes of FOSQ-10 as an indicator of sleep-related quality of life score over the course of treatment period [ Time Frame: 3 and 6 month after starting the treatment ]
  • The effect of sleep apnea treatment on blood pressure in people experiencing homelessness [ Time Frame: 3 and 6 month after starting the treatment ]
  • Contributing factors to adherence rate (number of nights with treatment usage >4 hours / total number of nights monitored) at months 3 and 6 post-treatment. [ Time Frame: 3 and 6 month after starting the treatment ]

Central Contacts and Locations

Locations

Dixon Hall

Recruiting

Toronto, Ontario, Canada, M4C 1L7

Contacts

Haydar Shouly

416.849.5952haydar.shouly@dixonhall.org

Fred Victor

Recruiting

Toronto, Ontario, Canada, M5S 3A9

Contacts

Andrew Legatto

alegatto@fredvictor.org

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-10-01.