Patient Outcomes in Unattended and In- Lab Polysomnography
NCT05230394 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194
Last updated 2023-02-08
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.
Conditions
- Sleep Apnea
- Hypersomnia
Interventions
- DIAGNOSTIC_TEST
-
Attended Polysomnography in the Lab
Using standard Level 1 polysomnography
- DIAGNOSTIC_TEST
-
Unattended Polysomnography in the Home
Using Cerebra's Prodigy system
Sponsors & Collaborators
-
University of Manitoba
collaborator OTHER -
Cerebra Medical
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-31
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Canada
Study Locations
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