Patient Outcomes in Unattended and In- Lab Polysomnography

Study Overview
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Brief Summary
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This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.

Detailed Description
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Individuals referred to the Sleep Disorder Centre with a major complaint of snoring or, apneas or hypersomnia, with at least one additional minor concern of snoring, apneas, restless leg syndrome or insomnia, will be considered for entry into the study. Using a randomized controlled trial design, study participants will be randomly assigned to either the intervention group who will undergo a full unattended polysomnography (level 2 home sleep study) using the Prodigy portable wireless sleep monitor or in-lab polysomnography (level 1 sleep study). Other aspects of care including the clinical assessment will be equivalent between groups. A randomly assigned sleep specialist physician will make treatment recommendations to the patient based on the sleep study results and determine the need for a subsequent testing (including repeat sleep studies) as part of each patient encounter. Physicians participating in the study will receive an introduction to the Odds Ratio Product (ORP) and training on its diagnostic potential. Diagnostic confidence using a 5 point Likert scale from 10% (very unsure) to 90% (very confident) will be assessed after each sleep study review.

Official Title
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Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders

Conditions
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Sleep Apnea, Hypersomnia

Intervention / Treatment
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* Diagnostic Test: Attended Polysomnography in the Lab
* Diagnostic Test: Unattended Polysomnography in the Home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referral for major concern of snoring or apnea or hypersomnia with additional minor concerns of snoring, apneas restless leg syndrome or insomnia willing to undergo a sleep study Exclusion Criteria: referrals where parasomnias, respiratory failure, narcolepsy listed as concerns comorbid congestive heart failure, ischemic heart disease, arrhythmia, stroke, chronic obstructive pulmonary disease/respiratory failure, patients with a BMI 50 kg/m2 undergone a previous sleep study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Level 1 In Lab Polysomnography<br> | Diagnostic Test: Attended Polysomnography in the Lab<br>* Using standard Level 1 polysomnography<br>|
| Experimental: Level 2 In Home Polysomnography<br> | Diagnostic Test: Unattended Polysomnography in the Home<br>* Using Cerebra's Prodigy system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Outcomes of Sleep Questionnaire | Total Score scale ranges from 5-20, with higher scores representing better functioning | 4 months | 
| Change in Epworth Sleepiness Scale | Scale ranges from 0-24, with higher scores representing more sleepiness | 4 months | 
| Continuous Positive Airway Pressure (CPAP) Adherence | Percent of nights with CPAP > 4 hours/night | 4 months | 
| Change in Calgary Sleep Apnea Quality of Life Index | Total score ranges from 1-7, with a greater score indicating a lower effect of OSA on quality of life | 4 months | 
| Rating of Physician Diagnostic Confidence | Likert scale rating performed by physicians to assess confidence in diagnosis from data provided by the two systems, scale from 1-5 with higher values reflecting greater confidence | within 4 weeks of sleep study, after patient assessment by physician | 
| Rating of Patient Satisfaction | Likert scale rating of patient satisfaction for their sleep study experience, ranges from 1-7 with higher values reflecting greater satisfaction | Measured in morning following their sleep study | 
| Cost between Level 1 and Level 2 tests based on equipment, facility, supply costs, and technician and physician service fees |  | After study conclusion, an average of up to 1 year |