Obstructive Sleep ApneaMuscle-OSANCT06334601
Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness
An observational study of Obstructive Sleep Apnea, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Tests of upper airway collapsibility and muscle responsiveness.
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2023to 31 Dec 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients evaluated for sleep disorders in our Institution, who present an at home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index >14)
Who may be able to join
- Obstructive Sleep Apnea (OSA)
- At home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index >14).
Who cannot join
- OSA treatment ongoing during two weeks before PSG
- Unstable cardio-respiratory disease in the 3 months before enrollment
- Subjects in O2 treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Auxologico Italiano,Ospedale San Luca
Milan, 20145
Elisa Perger, MD, +390261911 ext. 2705, e.perger@auxologico.it
About this study
Official title: Diurnal Evaluation of Obstructive Sleep Apnea (OSA) Upper Airway Collapsibility and Muscle Responsiveness
In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Tests of upper airway collapsibility and muscle responsiveness.
- Keywords
- Collapsibility of upper airways, Muscle responsiveness
- 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.
Tests of upper airway collapsibility and muscle responsiveness.Diagnostic test
Upper airway collapsibility, upper airway muscle responsiveness and loop gain will be assessed during single study visit.
Polysomnography
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Patients evaluated for sleep disorders, who present an at home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index >14). Receives: Diagnostic Test: Tests of upper airway collapsibility and muscle responsiveness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper airway collapsibility
Evaluation during wakefulness
Measured: During the diagnostic test
Upper airway muscle responsiveness
Evaluation during wakefulness
Measured: During the diagnostic test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start15 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334601
- Sponsor's protocol ID
- 09C333
- Acronym
- Muscle-OSA
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2024
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Evaluation of Obstructive Sleep Apnea (OSA) Upper Airway Collapsibility and Muscle Responsiveness
- ClinicalTrials.gov ID
- NCT06334601
- Acronym / sponsor ID
- Muscle-OSA / 09C333
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Collapsibility of upper airways, Muscle responsiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Mar 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.
In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | Diagnostic Test: Tests of upper airway collapsibility and muscle responsiveness.Patients evaluated for sleep disorders, who present an at home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index >14). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients evaluated for sleep disorders in our Institution, who present an at home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index >14)
Key inclusion criteria (2 listed)
- Obstructive Sleep Apnea (OSA)
- At home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index >14).
Key exclusion criteria (3 listed)
- OSA treatment ongoing during two weeks before PSG
- Unstable cardio-respiratory disease in the 3 months before enrollment
- Subjects in O2 treatment
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 |
|---|---|---|
| Tests of upper airway collapsibility and muscle responsiveness.Upper airway collapsibility, upper airway muscle responsiveness and loop gain will be assessed during single study visit. Polysomnography | Diagnostic test | Obstructive Sleep Apnea |
Primary outcome
Upper airway collapsibility
Time frame: During the diagnostic test
Evaluation during wakefulness
Upper airway muscle responsiveness
Time frame: During the diagnostic test
Evaluation during wakefulness
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 30 Apr 2025.
- 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.
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 Apnea, run by Istituto Auxologico Italiano at 1 site in Italy.
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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. 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 Italy. 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?
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?
Contact Elisa Perger, MD (+390261911 ext. 2705, e.perger@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper airway collapsibility (time frame: During the diagnostic 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 30 Apr 2025.