Obstructive Sleep Apnea (OSA)NCT07688603
Level 3 Validation Study
A study testing Comparison 1: Level 1 Polysomnography: Cadwell/Alice and Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor in people with Obstructive Sleep Apnea (OSA), run by Windsor Sleep Disorders Clinic.
Trial summary
This study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Comparison 1: Level 1 Polysomnography: Cadwell/Alice and Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Referred for a diagnostic sleep study
Who cannot join
- under the age of 18
- significant cardiopulmonary disease, neuromuscular disease or stroke
- other significant sleep disorders
- use of opiate medications
About this study
Official title: Comparison of Home Level 3 Polysomnography to In-Laboratory Polysomnography
This study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Comparison 1: Level 1 Polysomnography: Cadwell/Alice, Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison 1: Level 1 Polysomnography: Cadwell/AliceDevice
Also called Cadwell, Alice
Gold standard measurement of sleep to compare against.
Comparison 2: Level 3 Test: Berry Sleep Apnea Screening MonitorDevice
Also called Berry Sleep Apnea Screening Monitor
Novel Level 3 test under development.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Laboratory Patients | Experimental | Not described Receives: Device: Comparison 1: Level 1 Polysomnography: Cadwell/Alice; Device: Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apneas
Frequency of apneas (events per hour)
Measured: 1 night recording per test
Oxygen Saturation
Oxygen saturation (%)
Measured: 1 Night recording per test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Windsor Sleep Disorders Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688603
- Sponsor's protocol ID
- Level3Validation
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Home Level 3 Polysomnography to In-Laboratory Polysomnography
- ClinicalTrials.gov ID
- NCT07688603
- Acronym / sponsor ID
- Level3Validation
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Windsor Sleep Disorders ClinicUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Jul 2026 (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 study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Laboratory Patients | Experimental | Device: Comparison 1: Level 1 Polysomnography: Cadwell/Alice, Device: Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred for a diagnostic sleep study
Key exclusion criteria (4 listed)
- under the age of 18
- significant cardiopulmonary disease, neuromuscular disease or stroke
- other significant sleep disorders
- use of opiate medications
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 |
|---|---|---|
| Comparison 1: Level 1 Polysomnography: Cadwell/AliceAlso: Cadwell, AliceGold standard measurement of sleep to compare against. | Device | Sleep Laboratory Patients |
| Comparison 2: Level 3 Test: Berry Sleep Apnea Screening MonitorAlso: Berry Sleep Apnea Screening MonitorNovel Level 3 test under development. | Device | Sleep Laboratory Patients |
Primary outcome
Apneas
Time frame: 1 night recording per test
Frequency of apneas (events per hour)
Oxygen Saturation
Time frame: 1 Night recording per test
Oxygen saturation (%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison 1: Level 1 Polysomnography: Cadwell/Alice and Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor in people with Obstructive Sleep Apnea (OSA), run by Windsor Sleep Disorders Clinic.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Apneas (time frame: 1 night recording per test). The study lists 2 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 7 Jul 2026.