Sleep Apnea, ObstructivePVaNCT05949853
Enhanced Respiratory Polygraphy in Suspected OSA
An observational study of Sleep Apnea, Obstructive, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Obstructive Sleep Apnea (OSA) remains underdiagnosed in 2022, as a result of the unawareness of its serious health-related consequences and the lack of diagnosis accessibility. Respiratory polygraphy (PV) is widely used as a screening tool and sometimes a diagnosis test, although polysomnography (PSG) remains the gold… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- the respiratory parameters (AHI) and time spent
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Dec 2023
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Hospitalized at the Center for Sleep Medicine and Respiratory Diseases
Who may be able to join
- Hospitalized at the Center for Sleep Medicine and Respiratory Diseases, Hôpital de la Croix-Rousse, Lyon Academic Hospital, Lyon between 09/2022 and 11/2022 for PSG following suspected OSA .
Who cannot join
- Unreliable sleep scoring due to artefacts (> 10% of the recording) or to epileptic abnormalities on the electroencephalography recordings
- Presence of other suspected sleep disorder: central hypersomnia, rapid-eye-movement (REM) or non-REM sleep parasomnia, sleep-related motor disorders...
- Ongoing psychotropic medication
- Opposition of the patient to the use of their data.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine du sommeil et des maladies respiratoires
Lyon, 69004
About this study
Official title: Enhanced Respiratory Polygraphy (PV_e) Using Single Channel EEG-based Automatic Sleep Scoring in Suspected Obstructive Sleep Apnea: Feasibility and Efficiency as Compared With Polygraphy and Polysomnography
Obstructive Sleep Apnea (OSA) remains underdiagnosed in 2022, as a result of the unawareness of its serious health-related consequences and the lack of diagnosis accessibility. Respiratory polygraphy (PV) is widely used as a screening tool and sometimes a diagnosis test, although polysomnography (PSG) remains the gold standard investigation as it provides complete information about sleep architecture and arousals. Thus, it has been shown that the Apnea Hypopnea Index (AHI) and Respiratory Disorder Index (RDI) are underestimated by PV vs PSG. Approaches to substitute PSG by simpler but equally efficient diagnosis tests have included devices aiming to record complementary signals and to analyze them with Artificial Intelligence. In this context, ASEEGA algorithm has demonstrated its performance for automatic sleep scoring in healthy individuals and patients with various sleep disorders, based on a single channel EEG analysis.
This study aims at comparing the real-life performance and feasibility of added single channel EEG automatic sleep scoring using ASEEGA to PV versus standard PV and PSG in adults referred to a regional sleep reference center for suspected OSA.
We hypothesize that this approach (1) is as accurate as PSG and more accurate that PV for AHI analysis, and (2) is less time-consuming than PSG.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- the respiratory parameters (AHI) and time spent
- Keywords
- Polysomnography, Polygraphy, single channel EEG automated sleep scoring
- 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.
the respiratory parameters (AHI) and time spentOther
interpret the recording will be evaluated for PSG, PV and PV+ASEEGA Apnea Hypopnea Index as assessed by PSG (respiratory signals + electro-encephalography + electro-oculography + chin electromyography), PV (respiratory signals) and PV+ASEEGA (respiratory signals + result of sleep stages and arousals scoring by ASEEGA algorithm based on automatic analysis of one EEG Cz-Pz channel)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients hospitalized at the Center for Sleep and Respiratory Diseases, between 09/2022 and 11/2022 for suspected OSA All these patients underwent a full night polysomnography Receives: Other: the respiratory parameters (AHI) and time spent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index as assessed by PSG
Apnea Hypopnea Index will be scored by 2 sleep medical experts at 3 occurrences separated by 1 months interval in a random order (PSG/PV/PV+ASEEGA).
Apnea Hypopnea Index in the three groups (PSG/PV/PV+ASEEGA) will be compared with Friedmann test or one factor ANOVA for paired data, according to data distribution, for each scorer
Measured: analysis will start in January 2023 and should be completed after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949853
- Sponsor's protocol ID
- 69HCL23_0238
- Acronym
- PVa
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 13 Nov 2023
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Respiratory Polygraphy (PV_e) Using Single Channel EEG-based Automatic Sleep Scoring in Suspected Obstructive Sleep Apnea: Feasibility and Efficiency as Compared With Polygraphy and Polysomnography
- ClinicalTrials.gov ID
- NCT05949853
- Acronym / sponsor ID
- PVa / 69HCL23_0238
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Polysomnography, Polygraphy, single channel EEG automated sleep scoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 Jul 2023 (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.
Obstructive Sleep Apnea (OSA) remains underdiagnosed in 2022, as a result of the unawareness of its serious health-related consequences and the lack of diagnosis accessibility. Respiratory polygraphy (PV) is widely used as a screening tool and sometimes a diagnosis test, although polysomnography (PSG) remains the gold standard investigation as it provides complete information about sleep architecture and arousals. Thus, it has been shown that the Apnea Hypopnea Index (AHI) and Respiratory Disorder Index (RDI) are underestimated by PV vs PSG. Approaches to substitute PSG by simpler but equally efficient diagnosis tests have included devices aiming to record complementary signals and to analyze them with Artificial Intelligence. In this context, ASEEGA algorithm has demonstrated its performance for automatic sleep scoring in healthy individuals and patients with various sleep disorders, based on a single channel EEG analysis.
This study aims at comparing the real-life performance and feasibility of added single channel EEG automatic sleep scoring using ASEEGA to PV versus standard PV and PSG in adults referred to a regional sleep reference center for suspected OSA.
We hypothesize that this approach (1) is as accurate as PSG and more accurate that PV for AHI analysis, and (2) is less time-consuming than PSG.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: the respiratory parameters (AHI) and time spentPatients hospitalized at the Center for Sleep and Respiratory Diseases, between 09/2022 and 11/2022 for suspected OSA All these patients underwent a full night polysomnography |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Hospitalized at the Center for Sleep Medicine and Respiratory Diseases
Key inclusion criteria (1 listed)
- Hospitalized at the Center for Sleep Medicine and Respiratory Diseases, Hôpital de la Croix-Rousse, Lyon Academic Hospital, Lyon between 09/2022 and 11/2022 for PSG following suspected OSA .
Key exclusion criteria (4 listed)
- Unreliable sleep scoring due to artefacts (> 10% of the recording) or to epileptic abnormalities on the electroencephalography recordings
- Presence of other suspected sleep disorder: central hypersomnia, rapid-eye-movement (REM) or non-REM sleep parasomnia, sleep-related motor disorders...
- Ongoing psychotropic medication
- Opposition of the patient to the use of their data.
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 |
|---|---|---|
| the respiratory parameters (AHI) and time spentinterpret the recording will be evaluated for PSG, PV and PV+ASEEGA Apnea Hypopnea Index as assessed by PSG (respiratory signals + electro-encephalography + electro-oculography + chin electromyography), PV (respiratory signals) and PV+ASEEGA (respiratory signals + result of sleep stages and arousals scoring by ASEEGA algorithm based on automatic analysis of one EEG Cz-Pz channel) | Other | Patients |
Primary outcome
Apnea Hypopnea Index as assessed by PSG
Time frame: analysis will start in January 2023 and should be completed after 6 months.
Apnea Hypopnea Index will be scored by 2 sleep medical experts at 3 occurrences separated by 1 months interval in a random order (PSG/PV/PV+ASEEGA). Apnea Hypopnea Index in the three groups (PSG/PV/PV+ASEEGA) will be compared with Friedmann test or one factor ANOVA for paired data, according to data distribution, for each scorer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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?
An observational study of Sleep Apnea, Obstructive, run by Hospices Civils de Lyon at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 13 Nov 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 France. 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?
Apnea Hypopnea Index as assessed by PSG (time frame: analysis will start in January 2023 and should be completed after 6 months.). 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 13 Nov 2023.