Hypersomnia, Sleep Apnea
Conditions
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.
Interventions
DIAGNOSTIC_TESTAttended Polysomnography in the Lab
Using standard Level 1 polysomnography
DIAGNOSTIC_TESTUnattended Polysomnography in the Home
Using Cerebra's Prodigy system
Sponsors
University of Manitoba
Cerebra Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Outcomes of Sleep Questionnaire | 4 months | Total Score scale ranges from 5-20, with higher scores representing better functioning |
| Change in Epworth Sleepiness Scale | 4 months | Scale ranges from 0-24, with higher scores representing more sleepiness |
| Continuous Positive Airway Pressure (CPAP) Adherence | 4 months | Percent of nights with CPAP \> 4 hours/night |
| 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 |
| 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 |
| 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 | — |
Countries
Canada
Outcome results
None listed