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Osteopathy and Obstructive Sleep Apnea Syndrome

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ClinicalTrials.gov Identifier: NCT01193738
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Valerie Attali, Groupe Hospitalier Pitie-Salpetriere

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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Procedure: osteopathic compression of Pterygopalatine node Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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.
Study Start Date : September 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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
placebo osteopathic compression
Procedure: osteopathic compression of Pterygopalatine node
osteopathic compression of Pterygopalatine node




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. symptoms [ Time Frame: 48 hours ]
    OSA symptoms

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: September 2, 2010    Key Record Dates
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