Clinical trial NCT05230394: Patient Outcomes in Unattended and In- Lab Polysomnography
Official title: Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Sleep Apnea
Hypersomnia
Lead sponsor: Cerebra Medical
Sponsor class: INDUSTRY
Collaborators: name: University of Manitoba
First posted: 2022-02-08
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Functional Outcomes of Sleep Questionnaire
timeFrame: 4 months
measure: Change in Epworth Sleepiness Scale
timeFrame: 4 months
measure: Continuous Positive Airway Pressure (CPAP) Adherence
timeFrame: 4 months
measure: Change in Calgary Sleep Apnea Quality of Life Index
timeFrame: 4 months
measure: Rating of Physician Diagnostic Confidence
timeFrame: within 4 weeks of sleep study, after patient assessment by physician
measure: Rating of Patient Satisfaction
timeFrame: Measured in morning following their sleep study
measure: Cost between Level 1 and Level 2 tests based on equipment, facility, supply costs, and technician and physician service fees
timeFrame: After study conclusion, an average of up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Sleep Disorders Centre
state: Manitoba
Study officials:
References: