Patient Outcomes in Unattended and In- Lab Polysomnography

NCT05230394 | Suspended

• 1 other identifier: SDC Study
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Hypersomnia

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Level 1 In Lab Polysomnography

EXPERIMENTAL

Diagnostic Test: Attended Polysomnography in the Lab

Level 2 In Home Polysomnography

EXPERIMENTAL

Diagnostic Test: Unattended Polysomnography in the Home

Interventions

Attended Polysomnography in the Lab DIAGNOSTIC_TEST

Using standard Level 1 polysomnography

Level 1 In Lab Polysomnography

Unattended Polysomnography in the Home DIAGNOSTIC_TEST

Using Cerebra's Prodigy system

Level 2 In Home Polysomnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerebra Medical: lead
• University of Manitoba: collaborator

Study Sites (1)

Sleep Disorders Centre

Winnipeg, Manitoba, R3C 1A2, Canada

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: February 8, 2022
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)