Patient Outcomes in Unattended and In- Lab Polysomnography

NCT05230394 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2023-02-08

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230394 on ClinicalTrials.gov