Osteopathy and Obstructive Sleep Apnea Syndrome

NCT ID: NCT01193738

Last Updated: 2015-08-11

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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active osteopathic compression

osteopathic compression of Pterygopalatine node

Group Type ACTIVE_COMPARATOR

osteopathic compression of Pterygopalatine node

Intervention Type PROCEDURE

osteopathic compression of Pterygopalatine node

placebo osteopathic compression

placebo osteopathic compression

Group Type PLACEBO_COMPARATOR

osteopathic compression of Pterygopalatine node

Intervention Type PROCEDURE

osteopathic compression of Pterygopalatine node

Interventions

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osteopathic compression of Pterygopalatine node

osteopathic compression of Pterygopalatine node

Intervention Type PROCEDURE

Eligibility Criteria

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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

Exclusion Criteria

* 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
* dental extraction within 15 days before inclusion
* pharyngeal surgery in the past
* incapable adult
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valerie Attali

OTHER

Sponsor Role lead

Responsible Party

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Valerie Attali

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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valerie attali, MD

Role: PRINCIPAL_INVESTIGATOR

Federation des pathologies du sommeil

Locations

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Pathologies Du Sommeil Pitie Salpetriere

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29262824 (View on PubMed)

Other Identifiers

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ADOREP 2009-068

Identifier Type: OTHER

Identifier Source: secondary_id

2009-A01373-54

Identifier Type: -

Identifier Source: org_study_id

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