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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
194
Using standard Level 1 polysomnography
Using Cerebra's Prodigy system
Sleep Disorders Centre
Winnipeg, Manitoba, Canada
Change in Functional Outcomes of Sleep Questionnaire
Total Score scale ranges from 5-20, with higher scores representing better functioning
Time frame: 4 months
Change in Epworth Sleepiness Scale
Scale ranges from 0-24, with higher scores representing more sleepiness
Time frame: 4 months
Continuous Positive Airway Pressure (CPAP) Adherence
Percent of nights with CPAP \> 4 hours/night
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After study conclusion, an average of up to 1 year
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