Patient Outcomes in Unattended and In- Lab Polysomnography

NCT ID: NCT05230394

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2023-12-31

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.

Conditions

Sleep Apnea; Hypersomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Level 1 In Lab Polysomnography

Group Type: EXPERIMENTAL

Attended Polysomnography in the Lab

Intervention Type: DIAGNOSTIC_TEST

Using standard Level 1 polysomnography

Level 2 In Home Polysomnography

Group Type: EXPERIMENTAL

Unattended Polysomnography in the Home

Intervention Type: DIAGNOSTIC_TEST

Using Cerebra's Prodigy system

Interventions

Attended Polysomnography in the Lab

Using standard Level 1 polysomnography

Intervention Type: DIAGNOSTIC_TEST

Unattended Polysomnography in the Home

Using Cerebra's Prodigy system

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: collaborator

Cerebra Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sleep Disorders Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

SDC Study

Identifier Type: -

Identifier Source: org_study_id