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Osteopathy and Obstructive Sleep Apnea Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01193738
First Posted: September 2, 2010
Last Update Posted: August 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valerie Attali, Groupe Hospitalier Pitie-Salpetriere
  Purpose
The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).

Condition Intervention
Obstructive Sleep Apnea Syndrome Procedure: osteopathic compression of Pterygopalatine node

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.

Resource links provided by NLM:


Further study details as provided by Valerie Attali, Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • symptoms [ Time Frame: 48 hours ]
    OSA symptoms

  • adverse events [ Time Frame: 48 hours ]
    clinical evaluation of adverse events


Enrollment: 10
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo osteopathic compression
Procedure: osteopathic compression of Pterygopalatine node
osteopathic compression of Pterygopalatine node

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193738


Locations
France
Pathologies Du Sommeil Pitie Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Valerie Attali
Investigators
Principal Investigator: valerie attali, MD Federation des pathologies du sommeil
  More Information

Responsible Party: Valerie Attali, MD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT01193738     History of Changes
Other Study ID Numbers: 2009-A01373-54
ADOREP 2009-068 ( Other Identifier: ADOREP )
First Submitted: September 1, 2010
First Posted: September 2, 2010
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Valerie Attali, Groupe Hospitalier Pitie-Salpetriere:
osteopathy

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases