Obstructive SleepMWTBHNCT06700837
Hypoxic Burden and Sleepiness in Treated OSA Patients
An observational study of Obstructive Sleep and OSA, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The Maintenance of Wakefulness Test (MWT) is widely used to objectively assess sleepiness and make safety-related decisions and Epworth Sleepiness Scale (ESS) is the most used scale used to assess subjective sleepiness in sleep medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep, OSA
- What is being tested?
- Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apnea
- How many people
- 141 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study involves consecutive adult patients referred to the Center for Sleep and Respiratory Medicine for performance of MCT from September 2017 to January 2020.
Who may be able to join
- OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to March 2020.
Who cannot join
- - age \<18 years
- refusal to participate in the study
- diagnosis of central disorder of hypersomnolence
- missing data on the MWT
- Epworth Sleepiness Scale (ESS)
- apnea-hypopnea index (AHI).
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse
Lyon, 69317
About this study
Official title: Impact of Hypoxic Burden on Objective and Subjective Sleepiness in Patients Treated for Obstructive Sleep Apnea
The Maintenance of Wakefulness Test (MWT) is widely used to objectively assess sleepiness and make safety-related decisions and Epworth Sleepiness Scale (ESS) is the most used scale used to assess subjective sleepiness in sleep medicine.
Besides Obstructive Sleep Apnea measures are rapidly evolving and conventional measures such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) are increasingly being supplemented by measures of hypoxia such as hypoxic burden.
Read more
Residual AHI in treated OSA have limited predictive value for objective sleepiness. Therefore it seems particularly relevant to identify other predictors of both subjective and objective sleepiness.
This study aims at studying the influence of hypoxic burden as measure of both subjective or objective sleepiness.
We hypothesize that impaired nocturnal oxygenation might influence brain functioning during wakefulness and result in sleepiness as assessed by ESS and MWT.
- Conditions
- Obstructive Sleep, OSA
- Being tested
- Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apnea
- Keywords
- Polysomnography, Polygraphy, Hypoxic burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apneaOther
To determine whether hypoxic load is a predictive marker of objective residual sleepiness measured by MCT in a treated OSAHS population.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxic burden and Sleepiness in treated OSA patients | In this retrospective study, we reviewed the files of all patients with OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to January 2020.
All these patients underwent a full night polysomnography. Receives: Other: Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective residual sleepiness in a treated OSAHS population as measured by the Multiple Sleep Latency Test (MSLT) in relation to hypoxic load.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive SleepStudies 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Pierre TANKERE, MD, Msc, Principal investigator, Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700837
- Sponsor's protocol ID
- 23-5474
- Acronym
- MWTBH
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 2024
- Last updated
- 22 Nov 2024
- 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypoxic Burden on Objective and Subjective Sleepiness in Patients Treated for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06700837
- Acronym / sponsor ID
- MWTBH / 23-5474
- Conditions
- Obstructive Sleep, OSA
- Keywords
- Polysomnography, Polygraphy, Hypoxic burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 22 Nov 2024 (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.
The Maintenance of Wakefulness Test (MWT) is widely used to objectively assess sleepiness and make safety-related decisions and Epworth Sleepiness Scale (ESS) is the most used scale used to assess subjective sleepiness in sleep medicine.
Besides Obstructive Sleep Apnea measures are rapidly evolving and conventional measures such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) are increasingly being supplemented by measures of hypoxia such as hypoxic burden.
Residual AHI in treated OSA have limited predictive value for objective sleepiness. Therefore it seems particularly relevant to identify other predictors of both subjective and objective sleepiness.
This study aims at studying the influence of hypoxic burden as measure of both subjective or objective sleepiness.
We hypothesize that impaired nocturnal oxygenation might influence brain functioning during wakefulness and result in sleepiness as assessed by ESS and MWT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoxic burden and Sleepiness in treated OSA patients | – | Other: Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apneaIn this retrospective study, we reviewed the files of all patients with OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to January 2020. All these patients underwent a full night polysomnography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study involves consecutive adult patients referred to the Center for Sleep and Respiratory Medicine for performance of MCT from September 2017 to January 2020.
Key inclusion criteria (1 listed)
- OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to March 2020.
Key exclusion criteria (6 listed)
- - age \<18 years
- refusal to participate in the study
- diagnosis of central disorder of hypersomnolence
- missing data on the MWT
- Epworth Sleepiness Scale (ESS)
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 |
|---|---|---|
| Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apneaTo determine whether hypoxic load is a predictive marker of objective residual sleepiness measured by MCT in a treated OSAHS population. | Other | Hypoxic burden and Sleepiness in treated OSA patients |
Primary outcome
Objective residual sleepiness in a treated OSAHS population as measured by the Multiple Sleep Latency Test (MSLT) in relation to hypoxic load.
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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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.
Dr Pierre TANKERE, MD, Msc principal investigator
Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse
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 Obstructive Sleep and OSA, 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 6 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: finished, as of the sponsor's last update on 22 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective residual sleepiness in a treated OSAHS population as measured by the Multiple Sleep Latency Test (MSLT) in relation to hypoxic load. (time frame: 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 22 Nov 2024.