Patient Outcomes in Unattended and In- Lab Polysomnography

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05230394
• Other study ID #: SDC Study
• Status: Suspended
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Cerebra Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 194
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Hypersomnia
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Diagnostic Test:
• Attended Polysomnography in the Lab
Using standard Level 1 polysomnography
• Unattended Polysomnography in the Home
Using Cerebra's Prodigy system

Locations

Country	Name	City	State
Canada	Sleep Disorders Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Cerebra Medical	University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Outcomes of Sleep Questionnaire	Total Score scale ranges from 5-20, with higher scores representing better functioning	4 months
Primary	Change in Epworth Sleepiness Scale	Scale ranges from 0-24, with higher scores representing more sleepiness	4 months
Primary	Continuous Positive Airway Pressure (CPAP) Adherence	Percent of nights with CPAP > 4 hours/night	4 months
Primary	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
Primary	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
Primary	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
Primary	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