Digital Technology for Sleep and Homelessness

NCT06620601 | Recruiting DMC

• 1 other identifier: 20-5862
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• To assess the prevalence of sleep apnea in shelter residents.

  Understanding the prevalence of sleep apnea in people experiencing homelessness

  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

  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)

  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

  3 and 6 month after starting the treatment

Study Arms (3)

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.

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.

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)

Other: Questionnaires

Interventions

Portable Polysomnography DIAGNOSTIC_TEST

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

Diagnosis

Treatment 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.

Also known as: Continous Positive Airway Pressure, Mandibular advancement device

Treatment

Questionnaires OTHER

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).

Diagnosis; Screening; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Dixon Hall

Toronto, Ontario, M4C 1L7, Canada

RECRUITING

Fred Victor

Toronto, Ontario, M5S 3A9, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Wake Disorders; Sleep Deprivation; Parasomnias

Interventions

Therapeutics; Occlusal Splints; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist and Associate Professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: October 1, 2024
• Study Start: October 20, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)