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Behavioural Intervention

Digital Technology for Sleep Apnea (HNSLEEP Trial)

Toronto, Canada

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years old

Be older than 18 years old

Must not have

Requiring extensive dental treatment or periodontal disease with tooth mobility (for treatment study)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to diagnose and treat sleep apnea in people experiencing homelessness. Sleep apnea is a common sleep disorder that causes daytime fatigue and other health issues. Despite a high prevalence of sleep apnea

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Who is the study for?

This trial is for people experiencing homelessness in Canada who may have sleep disorders, including sleep apnea. It aims to diagnose and treat these conditions to improve their quality of life.Check my eligibility

What is being tested?

The study involves questionnaires, portable polysomnography (a type of sleep study), and treatment for diagnosed sleep disorders. The goal is to see how patient-centered treatment affects the participants' quality of life.See study design

What are the potential side effects?

Since this trial focuses on diagnosis and non-invasive treatments, side effects are minimal but could include discomfort from wearing the polysomnography device during sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need a lot of dental work or have gum disease with loose teeth.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes of FOSQ-10 as an indicator of sleep-related quality of life score over the course of treatment period

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.

The effect of sleep apnea treatment on blood pressure in people experiencing homelessness

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

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.

Group II: ScreeningExperimental Treatment1 Intervention

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)

Group III: DiagnosisExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treatment

2013

Completed Phase 2

~10240

0 / 2Eligibility criteria met