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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05230394
Other study ID # SDC Study
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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