Patient Outcomes in Unattended and In- Lab Polysomnography
- Conditions
- Sleep ApneaHypersomnia
- Interventions
- Diagnostic Test: Attended Polysomnography in the LabDiagnostic Test: Unattended Polysomnography in the Home
- Registration Number
- NCT05230394
- Lead Sponsor
- Cerebra Medical
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 194
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Level 1 In Lab Polysomnography Attended Polysomnography in the Lab - Level 2 In Home Polysomnography Unattended Polysomnography in the Home -
- Primary Outcome Measures
Name Time Method Change in Functional Outcomes of Sleep Questionnaire 4 months Total Score scale ranges from 5-20, with higher scores representing better functioning
Rating of Physician Diagnostic Confidence within 4 weeks of sleep study, after patient assessment by physician 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
Rating of Patient Satisfaction Measured in morning following their sleep study Likert scale rating of patient satisfaction for their sleep study experience, ranges from 1-7 with higher values reflecting greater satisfaction
Continuous Positive Airway Pressure (CPAP) Adherence 4 months Percent of nights with CPAP \> 4 hours/night
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 Change in Calgary Sleep Apnea Quality of Life Index 4 months Total score ranges from 1-7, with a greater score indicating a lower effect of OSA on quality of life
Change in Epworth Sleepiness Scale 4 months Scale ranges from 0-24, with higher scores representing more sleepiness
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sleep Disorders Centre
🇨🇦Winnipeg, Manitoba, Canada