Osteopathy and Obstructive Sleep Apnea Syndrome II

Phase 3

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Procedure: sham comparator; Procedure: Osteopathic manipulative treatment

• Registration Number: NCT01822743
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).

Detailed Description

Osteopathic compression will be compared to a sham manoeuvre in a cross over design on apnea hypopnea index, pharyngeal collapsibility and symptoms in patients suffering from OSA, and on symptoms and pharyngeal collapsibility in healthy subjects.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham comparator	sham comparator	sham Osteopathic pterygopalatine node compression
Osteopathic manipulative treatment	Osteopathic manipulative treatment	Osteopathic compression of pterygopalatine node

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index	24 hours

Secondary Outcome Measures

Name	Time	Method
Determination of pharyngeal critical pressure	30 min
Pharyngeal sensitivity test	24 hours
Daily clinical symptoms of osa	7 days
Inspiratory nasal pic flow	24 hours

Trial Locations

Locations (1)

Service des pathologies du sommeil, Pitié-Salpêtrière hospital; 🇫🇷 Paris, France