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

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.

Study Overview

• Status: Suspended
• Conditions: Sleep Apnea; Hypersomnia
• Intervention / Treatment: Diagnostic test: Attended Polysomnography in the Lab; Diagnostic test: Unattended Polysomnography in the Home

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.

• Study Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 1A2
      • Sleep Disorders Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Level 1 In Lab Polysomnography	Diagnostic test: Attended Polysomnography in the Lab; Using standard Level 1 polysomnography
EXPERIMENTAL: Level 2 In Home Polysomnography	Diagnostic test: Unattended Polysomnography in the Home; Using Cerebra's Prodigy system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Outcomes of Sleep Questionnaire	Total Score scale ranges from 5-20, with higher scores representing better functioning	4 months
Change in Epworth Sleepiness Scale	Scale ranges from 0-24, with higher scores representing more sleepiness	4 months
Continuous Positive Airway Pressure (CPAP) Adherence	Percent of nights with CPAP > 4 hours/night	4 months
Change in Calgary Sleep Apnea Quality of Life Index	Total score ranges from 1-7, with a greater score indicating a lower effect of OSA on quality of life	4 months
Rating of Physician Diagnostic Confidence	Likert scale rating performed by physicians to assess confidence in diagnosis from data provided by the two systems, scale from 1-5 with higher values reflecting greater confidence	within 4 weeks of sleep study, after patient assessment by physician
Rating of Patient Satisfaction	Likert scale rating of patient satisfaction for their sleep study experience, ranges from 1-7 with higher values reflecting greater satisfaction	Measured in morning following their sleep study
Cost between Level 1 and Level 2 tests based on equipment, facility, supply costs, and technician and physician service fees		After study conclusion, an average of up to 1 year

Collaborators and Investigators

• Sponsor: Cerebra Medical
• Collaborators: University of Manitoba

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2023
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (ACTUAL): February 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Disorders of Excessive Somnolence
• Other Study ID Numbers: SDC Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No