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OpenTrials
Completed

NCT Number: NCT01193738

Osteopathy and Obstructive Sleep Apnea Syndrome

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

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pathologies Du Sommeil Pitie Salpetriere

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

osteopathic compression of Pterygopalatine node

Procedure

osteopathic compression of Pterygopalatine node

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Valerie Attali

Other

Registry information

Official study title

a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 2, 2010
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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