Obstructive Sleep Apnea SyndromePhase 3OSTEOSAOSIINCT01822743
Osteopathy and Obstructive Sleep Apnea Syndrome II
A Phase 3 study testing Osteopathic manipulative treatment in people with Obstructive Sleep Apnea Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA). 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 Syndrome
- What is being tested?
- Osteopathic manipulative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Mar 2014
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female aged 18 years or more
- Obstructive sleep apnea syndrome with apnea/hypopnea index > or = 15/hour
- Body mass Index <40kg/m2
- Male or Female aged ≥18 and ≤ 40 years
- No obstructive sleep apnea syndrome
- Body mass Index <30kg/m2
- No chronicle respiratory, neurological, cardiac or able to deteriorate sleep quality disease
- Low obstructive sleep apnea syndrome probability measured with Berlin Scale
Who cannot join
- Pregnant or lactating women
- Participating to another trial
- Acute infectious disease of upper respiratory airway tract at inclusion
- Complete nasal obstruction
- Facial neuralgia at inclusion
- Patients not able to stop treatment for OSA within one week before each visit
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- Allergy to latex
- Dental extraction within 15 days before inclusion
- Pharyngeal surgery in the past
- Incapable adult
- Patients treated with Selective Serotonin Reuptake Inhibitor
- Healthy Volunteers
- Pregnant or lactating women
- Participating to another trial
- Acute infectious disease of upper respiratory airway tract at inclusion
- Complete nasal obstruction
- Facial neuralgia at inclusion
- allergy to latex
- dental extraction within 15 days before inclusion
- pharyngeal surgery in the past
- incapable adult
- patients treated background treatment
Trial locations and contacts
1 site in 1 country.
France1 site
Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Paris, 75013
About this study
Official title: A Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Sham in Patients With Obstructive Sleep Apnea Syndrome and in Healthy Subjects
The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).
Read the detailed description
Osteopathic compression will be compared to a sham manoeuvre in a cross over design on apnea hypopnea index, pharyngeal collapsibility and symptoms in patients suffering from OSA, and on symptoms and pharyngeal collapsibility in healthy subjects.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Osteopathic manipulative treatment, sham comparator
- Keywords
- Osteopathy, Sleep Apnea Syndromes, Obstructive Sleep Apnea, Pcrit, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentProcedure or surgery
Osteopathic compression of pterygopalatine node
sham comparatorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic manipulative treatment | Experimental | Osteopathic compression of pterygopalatine node Receives: Procedure: Osteopathic manipulative treatment |
| Sham comparator | Sham comparator | sham Osteopathic pterygopalatine node compression Receives: Procedure: sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index
Measured: 24 hours
Secondary outcomes (7)
Pharyngeal sensitivity test
Measured: 30 min
Determination of pharyngeal critical pressure
Measured: 24 hours
Daily clinical symptoms of osa
Measured: 7 days
Pharyngeal sensitivity test
Measured: 24 hours
Determination of pharyngeal critical pressure
Measured: 30 min
Inspiratory nasal pic flow
Measured: 30 min
Inspiratory nasal pic flow
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Attali, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822743
- Sponsor's protocol ID
- P111007
- Acronym
- OSTEOSAOSII
- Status last verified
- Jun 2014
- First submitted
- 28 Mar 2013
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
https://www.mdpi.com/1421774
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Sham in Patients With Obstructive Sleep Apnea Syndrome and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01822743
- Acronym / sponsor ID
- OSTEOSAOSII / P111007
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Osteopathy, Sleep Apnea Syndromes, Obstructive Sleep Apnea, Pcrit, Polysomnography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Apr 2013 (estimated)
- 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 main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).
Detailed description
Osteopathic compression will be compared to a sham manoeuvre in a cross over design on apnea hypopnea index, pharyngeal collapsibility and symptoms in patients suffering from OSA, and on symptoms and pharyngeal collapsibility in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic manipulative treatment | Experimental | Procedure: Osteopathic manipulative treatmentOsteopathic compression of pterygopalatine node |
| Sham comparator | Sham comparator | Procedure: sham comparatorsham Osteopathic pterygopalatine node compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female aged 18 years or more
- Obstructive sleep apnea syndrome with apnea/hypopnea index > or = 15/hour
- Body mass Index <40kg/m2
- Male or Female aged ≥18 and ≤ 40 years
- No obstructive sleep apnea syndrome
Key exclusion criteria (22 listed)
- Pregnant or lactating women
- Participating to another trial
- Acute infectious disease of upper respiratory airway tract at inclusion
- Complete nasal obstruction
- Facial neuralgia at inclusion
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 |
|---|---|---|
| Osteopathic manipulative treatmentOsteopathic compression of pterygopalatine node | Procedure or surgery | Osteopathic manipulative treatment |
| sham comparator | Procedure or surgery | Sham comparator |
Primary outcome
Apnea-hypopnea index
Time frame: 24 hours
7 secondary outcomes
Pharyngeal sensitivity test
Time frame: 30 min
Determination of pharyngeal critical pressure
Time frame: 24 hours
Daily clinical symptoms of osa
Time frame: 7 days
Pharyngeal sensitivity test
Time frame: 24 hours
Determination of pharyngeal critical pressure
Time frame: 30 min
Inspiratory nasal pic flow
Time frame: 30 min
Inspiratory nasal pic flow
Time frame: 24 hours
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 25 Jan 2022.
- Results publicationhttps://www.mdpi.com/1421774
Related trials for Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Valérie Attali, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osteopathic manipulative treatment in people with Obstructive Sleep Apnea Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 22 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 25 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Apnea-hypopnea index (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822743, which also lists 1 linked publication.
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 25 Jan 2022.