Osteopathy and Obstructive Sleep Apnea Syndrome II

NCT ID: NCT01822743

Last Updated: 2022-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Osteopathic manipulative treatment

Osteopathic compression of pterygopalatine node

Group Type EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type PROCEDURE

Osteopathic compression of pterygopalatine node

Sham comparator

sham Osteopathic pterygopalatine node compression

Group Type SHAM_COMPARATOR

sham comparator

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Osteopathic manipulative treatment

Osteopathic compression of pterygopalatine node

Intervention Type PROCEDURE

sham comparator

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valérie Attali, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service des pathologies du sommeil, Pitié-Salpêtrière hospital

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

https://www.mdpi.com/1421774

Reference Type RESULT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P111007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Myofunctional Therapy for Children With OSA
NCT07249944 NOT_YET_RECRUITING NA