NCT05230394

Patient Outcomes in Unattended and In- Lab Polysomnography

Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Cerebra Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Apnea
• Hypersomnia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Attended Polysomnography in the Lab	Using standard Level 1 polysomnography
DIAGNOSTIC_TEST	Unattended Polysomnography in the Home	Using Cerebra's Prodigy system

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Canada