Osteopathy and Obstructive Sleep Apnea Syndrome

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

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

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

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Procedure: osteopathic compression of Pterygopalatine node


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active osteopathic compression<br>osteopathic compression of Pterygopalatine node | Procedure: osteopathic compression of Pterygopalatine node<br>* osteopathic compression of Pterygopalatine node<br>|
| Placebo Comparator: placebo osteopathic compression<br>placebo osteopathic compression | Procedure: osteopathic compression of Pterygopalatine node<br>* osteopathic compression of Pterygopalatine node<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal critical pressure | 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 | 30 minutes after osteopathic compression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal critical pressure | 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 | 48 hours | 
| symptoms | OSA symptoms | 48 hours | 
| adverse events | clinical evaluation of adverse events | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteopathy