Sleep ApneaNCT05230394
Patient Outcomes in Unattended and In- Lab Polysomnography
A study testing Attended Polysomnography in the Lab and Unattended Polysomnography in the Home in people with Sleep Apnea and Hypersomnia, run by Cerebra Medical at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Hypersomnia
- What is being tested?
- Attended Polysomnography in the Lab and Unattended Polysomnography in the Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Hypersomnia
- Being tested
- Attended Polysomnography in the Lab, Unattended Polysomnography in the Home
- Medical subject headings
- Sleep Apnea Syndromes, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attended Polysomnography in the LabDiagnostic test
Using standard Level 1 polysomnography
Unattended Polysomnography in the HomeDiagnostic test
Using Cerebra's Prodigy system
| Study group | Role | What they receive |
|---|---|---|
| Level 1 In Lab Polysomnography | Experimental | Not described Receives: Diagnostic Test: Attended Polysomnography in the Lab |
| Level 2 In Home Polysomnography | Experimental | Not described Receives: Diagnostic Test: Unattended Polysomnography in the Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Outcomes of Sleep Questionnaire
Total Score scale ranges from 5-20, with higher scores representing better functioning
Measured: 4 months
Change in Epworth Sleepiness Scale
Scale ranges from 0-24, with higher scores representing more sleepiness
Measured: 4 months
Continuous Positive Airway Pressure (CPAP) Adherence
Percent of nights with CPAP > 4 hours/night
Measured: 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
Measured: 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
Measured: 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: 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
Measured: After study conclusion, an average of up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Funding Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerebra Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Manitoba
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230394
- Sponsor's protocol ID
- SDC Study
- Status last verified
- Feb 2023
- First submitted
- 30 Dec 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders
- ClinicalTrials.gov ID
- NCT05230394
- Acronym / sponsor ID
- SDC Study
- Conditions
- Sleep Apnea, Hypersomnia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding Issues
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Cerebra MedicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Manitoba
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attended Polysomnography in the LabUsing standard Level 1 polysomnography | Diagnostic test | Level 1 In Lab Polysomnography |
| Unattended Polysomnography in the HomeUsing Cerebra's Prodigy system | Diagnostic test | Level 2 In Home Polysomnography |
Primary outcome
Change in Functional Outcomes of Sleep Questionnaire
Time frame: 4 months
Total Score scale ranges from 5-20, with higher scores representing better functioning
Change in Epworth Sleepiness Scale
Time frame: 4 months
Scale ranges from 0-24, with higher scores representing more sleepiness
Continuous Positive Airway Pressure (CPAP) Adherence
Time frame: 4 months
Percent of nights with CPAP > 4 hours/night
Change in Calgary Sleep Apnea Quality of Life Index
Time frame: 4 months
Total score ranges from 1-7, with a greater score indicating a lower effect of OSA on quality of life
Rating of Physician Diagnostic Confidence
Time frame: within 4 weeks of sleep study, after patient assessment by physician
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
Rating of Patient Satisfaction
Time frame: Measured in morning following their sleep study
Likert scale rating of patient satisfaction for their sleep study experience, ranges from 1-7 with higher values reflecting greater satisfaction
Cost between Level 1 and Level 2 tests based on equipment, facility, supply costs, and technician and physician service fees
Time frame: After study conclusion, an average of up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attended Polysomnography in the Lab and Unattended Polysomnography in the Home in people with Sleep Apnea and Hypersomnia, run by Cerebra Medical at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Outcomes of Sleep Questionnaire (time frame: 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.