Sleep Apnea Clinical Trial
Official title:
Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders
NCT number | NCT05230394 |
Other study ID # | SDC Study |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2023 |
Est. completion date | December 2023 |
Verified date | February 2023 |
Source | Cerebra Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 194 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sleep Disorders Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Cerebra Medical | University of Manitoba |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Functional Outcomes of Sleep Questionnaire | Total Score scale ranges from 5-20, with higher scores representing better functioning | 4 months | |
Primary | Change in Epworth Sleepiness Scale | Scale ranges from 0-24, with higher scores representing more sleepiness | 4 months | |
Primary | Continuous Positive Airway Pressure (CPAP) Adherence | Percent of nights with CPAP > 4 hours/night | 4 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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