Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06620601

Diagnosis and Treatment of Sleep Apnea in Shelter Residents Using Portable Polysomnography and Patient-Centered Treatment

Led by University Health Network, Toronto · Updated on 2024-10-01

100

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying sleep apnea in people experiencing homelessness who live in shelters. Sleep apnea is a condition where breathing stops and starts during sleep, causing fatigue and low quality of life. This population may have a higher rate of undiagnosed sleep apnea due to barriers in healthcare access. The study aims to diagnose and treat sleep apnea using technology and telemedicine to improve quality of life and health outcomes for shelter residents. Participants will have their sleep apnea assessed using a portable polysomnography device called Prodigy 2, which measures breathing, heart function, oxygen levels, and sleep stages overnight. Those diagnosed with sleep apnea and eligible for treatment will be offered options including auto-titrating CPAP or a mandibular advancement device based on clinical guidelines and personal preferences. Participants will also complete several questionnaires related to sleep, fatigue, depression, asthma control, and other health factors. Throughout the study, researchers will monitor sleep data, apnea severity, treatment adherence, and quality of life changes over a period of up to six months after starting treatment. They will assess outcomes such as apnea prevalence, sleep-related quality of life, blood pressure effects, and factors influencing treatment use. The study will last up to four years and includes safety monitoring and follow-up visits to better understand sleep apnea in this vulnerable group.

CONDITIONS

Brief Title

Digital Technology for Sleep and Homelessness

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Residing in a shelter at the time of recruitment
  • Age over 18 years old
Not Eligible

You will not qualify if you...

  • Allergies to medical tape for the diagnosis study
  • Requiring extensive dental treatment or having periodontal disease with tooth mobility for the treatment study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 night for polysomnography and one session for questionnaires

Participants undergo an overnight sleep study using a portable polysomnography device to assess for obstructive sleep apnea. They also complete questionnaires with the help of a research assistant to evaluate sleep, health, and related conditions.

1 baseline visit (in-person) and 1 overnight sleep study

Treatment

Duration - 6 months

Participants diagnosed with sleep apnea receive patient-centered treatment using either Auto-CPAP or a mandibular advancement device (MAD) based on physician recommendations and participant preference.

Visits as needed for treatment initiation and follow-up

Follow-up

Duration - Up to 6 months after starting treatment

Participants are monitored to assess treatment effects on sleep-related quality of life, blood pressure, and treatment adherence over time.

Visits at 3 and 6 months post-treatment start

Trial Site Locations

Total: 2 locations

1

Dixon Hall

Toronto, Ontario, Canada, M4C 1L7

Actively Recruiting

2

Fred Victor

Toronto, Ontario, Canada, M5S 3A9

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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