Digital Technology for Sleep and Homelessness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Residing in a shelter at the time of recruitment
Age >18 years old
Disqualifiers
Allergies to medical tape [for diagnosis study].
Requiring extensive dental treatment or periodontal disease with tooth mobility [for treatment study].
Trial design
Design model
Single group
Treatments tested in this trial
Portable Polysomnography
Diagnostic testResearch assistants set up the portable polysomnography (Prodigy) for the overnight sleep study.
Treatment
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.
Questionnaires
Other interventionParticipants 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).
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: DiagnosisExperimental treatment 2 interventions
Group B: TreatmentExperimental treatment 2 interventions
Group C: ScreeningOther 1 intervention
Trial outcomes
Primary outcomes
1
To assess the prevalence of sleep apnea in shelter residents.
Understanding the prevalence of sleep apnea in people experiencing homelessness
Time frame
up to 4 years.2
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
Time frame
3 and 6 month after starting the treatment3
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)
Time frame
3 and 6 month after starting the treatment4
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
Time frame
3 and 6 month after starting the treatmentSponsors and contacts
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Source ClinicalTrials.gov