Osteopathy and Obstructive Sleep Apnea Syndrome

August 10, 2015 updated by: Valerie Attali

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Pathologies Du Sommeil Pitie Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: active osteopathic compression
osteopathic compression of Pterygopalatine node
Procedure: osteopathic compression of Pterygopalatine node
osteopathic compression of Pterygopalatine node
PLACEBO_COMPARATOR: placebo osteopathic compression
Procedure: osteopathic compression of Pterygopalatine node
osteopathic compression of Pterygopalatine node

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes after osteopathic compression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharyngeal critical pressure
Time Frame: 48 hours
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
48 hours
symptoms
Time Frame: 48 hours
OSA symptoms
48 hours
adverse events
Time Frame: 48 hours
clinical evaluation of adverse events
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valerie Attali

Investigators

  • Principal Investigator: valerie attali, MD, Federation des Pathologies du Sommeil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (ESTIMATE)

September 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A01373-54
  • ADOREP 2009-068 (OTHER: ADOREP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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