Clinical trial NCT06620601: Digital Technology for Sleep and Homelessness
Official title: Diagnosis and Treatment of Sleep Apnea in Shelter Residents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Sleep Disorder
Sleep Deprivation
Sleep Disturbance
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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:

1. Assess the prevalence of sleep apnea in shelter residents
2. 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.

Eligibility criteria: 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 \[for treatment study\].

Primary outcomes:
measure: To assess the prevalence of sleep apnea in shelter residents.
timeFrame: up to 4 years.
measure: Changes of FOSQ-10 as an indicator of sleep-related quality of life score over the course of treatment period
timeFrame: 3 and 6 month after starting the treatment
measure: The effect of sleep apnea treatment on blood pressure in people experiencing homelessness
timeFrame: 3 and 6 month after starting the treatment
measure: 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.
timeFrame: 3 and 6 month after starting the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dixon Hall
state: Ontario
city: Toronto
country: Canada
facility: Fred Victor
state: Ontario
Study officials:
References: