Sleep ApneaHNSLEEPNCT06620601
Digital Technology for Sleep and Homelessness
A study testing Portable Polysomnography, Treatment and Questionnaires in people with Sleep Apnea and Sleep Disorder, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Sleep Disorder, Sleep Deprivation
- What is being tested?
- Portable Polysomnography, Treatment and Questionnaires
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Oct 2021to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residing in a shelter at the time of recruitment
- Age >18 years old
Who cannot join
- Allergies to medical tape [for diagnosis study].
- Requiring extensive dental treatment or periodontal disease with tooth mobility [for treatment study].
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Dixon Hall
Toronto, Ontario, M4C 1L7
Haydar Shouly, 416.849.5952, haydar.shouly@dixonhall.org
- Recruiting
Fred Victor
Toronto, Ontario, M5S 3A9
Andrew Legatto, alegatto@fredvictor.org
About this study
Official title: Diagnosis and Treatment of Sleep Apnea in Shelter Residents
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.
Read the detailed description
Background:
Disadvantaged individuals, including people experiencing homelessness, are at higher risk of getting infected, transmitting disease, and having poor health outcomes. Access to medical care, even within a system of universal health insurance like that of Canada, is decreased among people experiencing homelessness, but available evidence has demonstrated the efficacy of using telemedicine to reach vulnerable people in remote areas or people experiencing homelessness. However, at present, telemedicine-facilitated care in Canada is predominantly devoid of any technology to evaluate patient vital signals. The application of such technology to this population, if feasible, could have transformational implications for monitoring and management of such disadvantaged populations. Currently, it is known that there is a greater prevalence of chronic health diseases such as asthma, cardiology, and respiratory diseases in people experiencing homelessness. But there is no literature on the prevalence of obstructive sleep apnea (OSA) in the people experiencing homelessness. OSA is a condition characterized by repeated episodes of breathing cessation during sleep. Patients with OSA can suffer from daytime sleepiness, fatigue, and lack of energy. OSA is also associated with the conditions that account for the leading causes of mortality in adults: hypertension, cardiovascular, and cerebrovascular diseases. Seeing as the people experiencing homelessness already face many societal barriers to healthcare access, it is likely that there may exist a higher prevalence of undiagnosed OSA among the people experiencing homelessness.
Rationale:
From past studies, chronic diseases have been shown to be of higher prevalence in the people experiencing homelessness versus the general population, with an emphasis on a high prevalence of asthma and hypertension in the people experiencing homelessness. There is already a well-established connection between the prevalence of OSA in patients who have asthma and/or hypertension and OSA is already a highly undiagnosed condition in the general population. OSA also contributes to many other chronic health conditions. Given the strong association of hypertension and asthma with OSA, and the above average prevalence of both asthma and hypertension, among other chronic diseases, in this population, it is reasonable to infer that there might also be a high prevalence of undiagnosed OSA among the people experiencing homelessness. The use of technology and telemedicine will decrease the barriers in receiving care for people experiencing homelessness and allow for ease of access to diagnose OSA.
Inclusion/Exclusion Criteria:
The eligibility criteria for participants will include residing in a shelter at the time of recruitment, and being >18 years old. Participants with allergies to medical tape will be excluded from the study. For treatment protocol, exclusion criteria for mandibular advancement treatment will be dental and oral health requiring extensive dental treatment or periodontal disease with tooth mobility.
Hypotheses:
The investigators hypothesize that the prevalence of obstructive sleep apnea in the people experiencing homelessness will exceed that observed in the general population, as do the associated conditions of hypertension and asthma. Furthermore, the investigators hypothesize that the use of technology will help to decrease barriers in diagnosing and providing treatment for OSA.
Primary Objectives:
- Assess the prevalence of sleep apnea in shelter residents
- Evaluate the effects of preferred sleep apnea treatment on quality of life of the people experiencing homelessness
Significance:
The investigators anticipate the results of this study to help lower barriers to healthcare and provide better health outcomes for people experiencing homelessness. This study will provide insight into the prevalence of OSA in people experiencing homelessness and the feasibility of using technology in telemedicine.
- Conditions
- Sleep Apnea, Sleep Disorder, Sleep Deprivation, Sleep Disturbance
- Being tested
- Portable Polysomnography, Treatment, Questionnaires
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Wake Disorders, Sleep Deprivation, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable PolysomnographyDiagnostic test
Research assistants set up the portable polysomnography (Prodigy) for the overnight sleep study.
TreatmentDevice
Also called Continous Positive Airway Pressure, Mandibular advancement device
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.
QuestionnairesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis | Experimental | 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. Receives: Diagnostic Test: Portable Polysomnography; Other: Questionnaires |
| Treatment | Experimental | 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. Receives: Device: Treatment; Other: Questionnaires |
| Screening | Other | 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) Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of sleep apnea in shelter residents.
Understanding the prevalence of sleep apnea in people experiencing homelessness
Measured: up to 4 years.
Changes of FOSQ-10 as an indicator of sleep-related quality of life score over the course of treatment period
Understanding the effect of providing treatment on different aspects of quality of life
Measured: 3 and 6 month after starting the treatment
The effect of sleep apnea treatment on blood pressure in people experiencing homelessness
Understanding the potential impact of sleep apnea treatment on blood pressure (as an index of cardiorespiratory condition)
Measured: 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.
To investigate the factors that affect the adherence to preferred sleep apnea treatment in people experiencing homelessness
Measured: 3 and 6 month after starting the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start20 Oct 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azadeh Yadollahi, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620601
- Sponsor's protocol ID
- 20-5862
- Acronym
- HNSLEEP
- Status last verified
- Sep 2024
- First submitted
- 6 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data contains sensitive information about the participants and data sharing with the teams outside of the University Health Network has never been considered in consents obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Sleep Apnea in Shelter Residents
- ClinicalTrials.gov ID
- NCT06620601
- Acronym / sponsor ID
- HNSLEEP / 20-5862
- Conditions
- Sleep Apnea, Sleep Disorder, Sleep Deprivation, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Disadvantaged individuals, including people experiencing homelessness, are at higher risk of getting infected, transmitting disease, and having poor health outcomes. Access to medical care, even within a system of universal health insurance like that of Canada, is decreased among people experiencing homelessness, but available evidence has demonstrated the efficacy of using telemedicine to reach vulnerable people in remote areas or people experiencing homelessness. However, at present, telemedicine-facilitated care in Canada is predominantly devoid of any technology to evaluate patient vital signals. The application of such technology to this population, if feasible, could have transformational implications for monitoring and management of such disadvantaged populations. Currently, it is known that there is a greater prevalence of chronic health diseases such as asthma, cardiology, and respiratory diseases in people experiencing homelessness. But there is no literature on the prevalence of obstructive sleep apnea (OSA) in the people experiencing homelessness. OSA is a condition characterized by repeated episodes of breathing cessation during sleep. Patients with OSA can suffer from daytime sleepiness, fatigue, and lack of energy. OSA is also associated with the conditions that account for the leading causes of mortality in adults: hypertension, cardiovascular, and cerebrovascular diseases. Seeing as the people experiencing homelessness already face many societal barriers to healthcare access, it is likely that there may exist a higher prevalence of undiagnosed OSA among the people experiencing homelessness.
Rationale:
From past studies, chronic diseases have been shown to be of higher prevalence in the people experiencing homelessness versus the general population, with an emphasis on a high prevalence of asthma and hypertension in the people experiencing homelessness. There is already a well-established connection between the prevalence of OSA in patients who have asthma and/or hypertension and OSA is already a highly undiagnosed condition in the general population. OSA also contributes to many other chronic health conditions. Given the strong association of hypertension and asthma with OSA, and the above average prevalence of both asthma and hypertension, among other chronic diseases, in this population, it is reasonable to infer that there might also be a high prevalence of undiagnosed OSA among the people experiencing homelessness. The use of technology and telemedicine will decrease the barriers in receiving care for people experiencing homelessness and allow for ease of access to diagnose OSA.
Inclusion/Exclusion Criteria:
The eligibility criteria for participants will include residing in a shelter at the time of recruitment, and being >18 years old. Participants with allergies to medical tape will be excluded from the study. For treatment protocol, exclusion criteria for mandibular advancement treatment will be dental and oral health requiring extensive dental treatment or periodontal disease with tooth mobility.
Hypotheses:
The investigators hypothesize that the prevalence of obstructive sleep apnea in the people experiencing homelessness will exceed that observed in the general population, as do the associated conditions of hypertension and asthma. Furthermore, the investigators hypothesize that the use of technology will help to decrease barriers in diagnosing and providing treatment for OSA.
Primary Objectives:
- Assess the prevalence of sleep apnea in shelter residents
- Evaluate the effects of preferred sleep apnea treatment on quality of life of the people experiencing homelessness
Significance:
The investigators anticipate the results of this study to help lower barriers to healthcare and provide better health outcomes for people experiencing homelessness. This study will provide insight into the prevalence of OSA in people experiencing homelessness and the feasibility of using technology in telemedicine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diagnosis | Experimental | Diagnostic Test: Portable Polysomnography, Other: QuestionnairesDescription: 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. |
| Treatment | Experimental | Device: Treatment, Other: QuestionnairesDescription: 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. |
| Screening | Other | Other: QuestionnairesAlso, 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Residing in a shelter at the time of recruitment
- Age >18 years old
Key exclusion criteria (2 listed)
- Allergies to medical tape [for diagnosis study].
- Requiring extensive dental treatment or periodontal disease with tooth mobility [for treatment study].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable PolysomnographyResearch assistants set up the portable polysomnography (Prodigy) for the overnight sleep study. | Diagnostic test | Diagnosis |
| TreatmentAlso: Continous Positive Airway Pressure, Mandibular advancement deviceBased 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. | Device | Treatment |
| QuestionnairesParticipants 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). | Other | Diagnosis, Screening, Treatment |
Primary outcome
To assess the prevalence of sleep apnea in shelter residents.
Time frame: up to 4 years.
Understanding the prevalence of sleep apnea in people experiencing homelessness
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
Understanding the effect of providing treatment on different aspects of quality of life
The effect of sleep apnea treatment on blood pressure in people experiencing homelessness
Time frame: 3 and 6 month after starting the treatment
Understanding the potential impact of sleep apnea treatment on blood pressure (as an index of cardiorespiratory condition)
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
To investigate the factors that affect the adherence to preferred sleep apnea treatment in people experiencing homelessness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. The data contains sensitive information about the participants and data sharing with the teams outside of the University Health Network has never been considered in consents obtained from participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Polysomnography, Treatment and Questionnaires in people with Sleep Apnea and Sleep Disorder, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the prevalence of sleep apnea in shelter residents. (time frame: up to 4 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024; AzTrials last refreshed its copy on 2 Nov 2026.