Osteopathy and Obstructive Sleep Apnea Syndrome

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Procedure: osteopathic compression of Pterygopalatine node

• Registration Number: NCT01193738
• Lead Sponsor: Valerie Attali

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
active osteopathic compression	osteopathic compression of Pterygopalatine node	osteopathic compression of Pterygopalatine node
placebo osteopathic compression	osteopathic compression of Pterygopalatine node	placebo osteopathic compression

Primary Outcome Measures

Name	Time	Method
pharyngeal critical pressure	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

Name	Time	Method
pharyngeal critical pressure	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	48 hours	OSA symptoms
adverse events	48 hours	clinical evaluation of adverse events

Trial Locations

Locations (1)

Pathologies Du Sommeil Pitie Salpetriere; 🇫🇷 Paris, France