Status:
SUSPENDED
Patient Outcomes in Unattended and In- Lab Polysomnography
Lead Sponsor:
Cerebra Medical
Collaborating Sponsors:
University of Manitoba
Conditions:
Sleep Apnea
Hypersomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 comorbidit...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT05230394
Start Date
August 1 2023
End Date
December 1 2023
Last Update
February 8 2023
Active Locations (1)
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1
Sleep Disorders Centre
Winnipeg, Manitoba, Canada, R3C 1A2