Sleep Apnea (Disorder)NCT05272449
Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep
A study testing Sleep apnea diagnosis in people with Sleep Apnea (Disorder), run by CIDELEC.
Trial summary
Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea (Disorder)
- What is being tested?
- Sleep apnea diagnosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2022to 28 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected obstructive sleep apnea
Who cannot join
- Lung infection
- Insomnia
About this study
Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.
- Conditions
- Sleep Apnea (Disorder)
- Being tested
- Sleep apnea diagnosis
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep apnea diagnosisDevice
Split-night
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of a disposable sound sensor for recording respiration during sleep | Experimental | PneaVoX sensor, CIDELEC Receives: Device: Sleep apnea diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyzable signal time
Percentage of the analyzable signal duration compared to the total recorded signal duration
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start28 Feb 2022 (estimated)
- Primary completion28 Apr 2022 (estimated)
- Study completion28 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea (Disorder)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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CIDELEC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272449
- Sponsor's protocol ID
- 2021-A02524-37
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 9 Mar 2022
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep
- ClinicalTrials.gov ID
- NCT05272449
- Acronym / sponsor ID
- 2021-A02524-37
- Conditions
- Sleep Apnea (Disorder)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CIDELECIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 28 Apr 2022 (estimated)
- Study completion
- 28 Apr 2022 (estimated)
- First posted
- 9 Mar 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.
Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of a disposable sound sensor for recording respiration during sleep | Experimental | Device: Sleep apnea diagnosisPneaVoX sensor, CIDELEC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with suspected obstructive sleep apnea
Key exclusion criteria (2 listed)
- Lung infection
- Insomnia
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 |
|---|---|---|
| Sleep apnea diagnosisSplit-night | Device | Evaluation of a disposable sound sensor for recording respiration during sleep |
Primary outcome
Analyzable signal time
Time frame: One night
Percentage of the analyzable signal duration compared to the total recorded signal duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep apnea diagnosis in people with Sleep Apnea (Disorder), run by CIDELEC.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. 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?
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?
Analyzable signal time (time frame: One night). 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 9 Mar 2022.