Osteopathy and Obstructive Sleep Apnea Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT01193738
First received: September 1, 2010
Last updated: September 27, 2010
Last verified: September 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • pharyngeal critical pressure [ Time Frame: 30 minutes after osteopathic compression ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    OSA symptoms

  • adverse events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    clinical evaluation of adverse events


Estimated Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: January 2012
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193738

Contacts
Contact: valerie attali, MD + 33 1 42 16 77 23 valerie.attali@psl.aphp.fr
Contact: thomas similowski, MD PhD + 33 1 42 16 77 52 thomas.similowski@psl.aphp.fr

Locations
France
Pathologies Du Sommeil Pitie Salpetriere Recruiting
Paris, France, 75013
Contact: valerie attali, MD    + 33 1 42 16 77 03    valerie.attali@psl.aphp.fr   
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Investigators
Principal Investigator: valerie attali, MD Federation des pathologies du sommeil
  More Information

No publications provided

Responsible Party: Dr Valerie Attali, ADOREP
ClinicalTrials.gov Identifier: NCT01193738     History of Changes
Other Study ID Numbers: 2009-A01373-54, ADOREP 2009-068
Study First Received: September 1, 2010
Last Updated: September 27, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
osteopathy

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

ClinicalTrials.gov processed this record on April 17, 2014