Obstructive Sleep Apnea SyndromeNCT01193738

Osteopathy and Obstructive Sleep Apnea Syndrome

A study testing osteopathic compression of Pterygopalatine node in people with Obstructive Sleep Apnea Syndrome, run by Valerie Attali at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea Syndrome
What is being tested?: osteopathic compression of Pterygopalatine node
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteFrance
Study dates: Sep 2010to Jan 2012
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

Male or Female aged 18 years or more
obstructive sleep apnea syndrome with apnea/hypopnea index > or = 15/hour
Body mass Index <40kg/m2

Who cannot join

pregnant or lactating women
participating to another trial
acute infectious disease of upper respiratory airway tract at inclusion
facial neuralgia at inclusion
patients not able to stop treatment for OSA within one week before each visit
allergy to latex

Show all 9Show fewer

dental extraction within 15 days before inclusion
pharyngeal surgery in the past
incapable adult

Trial locations and contacts

1 site in 1 country.

France1 site

Pathologies Du Sommeil Pitie Salpetriere
Paris, 75013

Other trials in France

About this study

Official title: a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.

The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).

Read the detailed description

Osteopathic compression will be compared to a placebo manoeuvre. Efficacy will be assessed by measuring pharyngeal collapsibility

Conditions: Obstructive Sleep Apnea Syndrome
Being tested: osteopathic compression of Pterygopalatine node
Keywords: osteopathy
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.

osteopathic compression of Pterygopalatine nodeProcedure or surgery
osteopathic compression of Pterygopalatine node

Study groups in NCT01193738
Study group	Role	What they receive
active osteopathic compression	Active comparator	osteopathic compression of Pterygopalatine node Receives: Procedure: osteopathic compression of Pterygopalatine node
placebo osteopathic compression	Placebo comparator	placebo osteopathic compression Receives: Procedure: osteopathic compression of Pterygopalatine node

What is being measured

The primary outcome is the main question the study is designed to answer.

pharyngeal critical pressure
The collapsibility of the upper airway will be evaluated by pharyngeal critical pressure,assessed by measuring the intraluminal pressure associated with the cessation of airflow
Measured: 30 minutes after osteopathic compression

Secondary outcomes (3)

pharyngeal critical pressure
The collapsibility of the upper airway will be evaluated by pharyngeal critical pressure,assessed by measuring the intraluminal pressure associated with the cessation of airflow
Measured: 48 hours
symptoms
OSA symptoms
Measured: 48 hours
adverse events
clinical evaluation of adverse events
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Jan 2012

First posted2 Sep 2010 (estimated)
Study startSep 2010
Primary completionDec 2011
Study completionJan 2012

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.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193738
Sponsor's protocol ID: 2009-A01373-54
Other IDs: ADOREP 2009-068
Status last verified: Aug 2015
First submitted: 1 Sep 2010
Last updated: 11 Aug 2015
Results posted: No
Data monitoring committee: No

Publications

Jacq O, Arnulf I, Similowski T, Attali V. Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study. BMC Complement Altern Med. 2017 Dec 20;17(1):546. doi: 10.1186/s12906-017-2053-0.
PubMed 29262824

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea

All Obstructive Sleep Apnea Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2015. 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 Placebo Compression in Obstructive Sleep Apnea Syndrome.
ClinicalTrials.gov ID: NCT01193738
Acronym / sponsor ID: 2009-A01373-54
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: osteopathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Valerie AttaliUniversity, hospital or other
Study start: Sep 2010
Primary completion: Dec 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 2 Sep 2010 (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 on sleep obstructive apnea syndrome (OSA).

Detailed description

Osteopathic compression will be compared to a placebo manoeuvre. Efficacy will be assessed by measuring pharyngeal collapsibility

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
active osteopathic compression	Active comparator	Procedure: osteopathic compression of Pterygopalatine nodeosteopathic compression of Pterygopalatine node
placebo osteopathic compression	Placebo comparator	Procedure: osteopathic compression of Pterygopalatine nodeplacebo osteopathic compression

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 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

Key exclusion criteria (9 listed)

pregnant or lactating women
participating to another trial
acute infectious disease of upper respiratory airway tract at inclusion
facial neuralgia at inclusion
patients not able to stop treatment for OSA within one week before each visit

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 compression of Pterygopalatine nodeosteopathic compression of Pterygopalatine node	Procedure or surgery	active osteopathic compression, placebo osteopathic compression

Primary outcome

pharyngeal critical pressure
Time frame: 30 minutes after osteopathic compression
The collapsibility of the upper airway will be evaluated by pharyngeal critical pressure,assessed by measuring the intraluminal pressure associated with the cessation of airflow

3 secondary outcomes

pharyngeal critical pressure
Time frame: 48 hours
symptoms
Time frame: 48 hours
adverse events
Time frame: 48 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 11 Aug 2015.
Derived from this study: PubMed 29262824Jacq O, Arnulf I, Similowski T, Attali V. Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study. BMC Complement Altern Med. 2017 Dec 20;17(1):546. doi: 10.1186/s12906-017-2053-0.

Related trials for Obstructive Sleep Apnea Syndrome

RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
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.

valerie attali, MD principal investigator

Federation des pathologies du sommeil

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing osteopathic compression of Pterygopalatine node in people with Obstructive Sleep Apnea Syndrome, run by Valerie Attali 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 3 inclusion and 9 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 11 Aug 2015. 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.

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?

pharyngeal critical pressure (time frame: 30 minutes after osteopathic compression). 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 NCT01193738, 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 11 Aug 2015.