Osteopathy and Obstructive Sleep Apnea Syndrome II

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Sham in Patients With Obstructive Sleep Apnea Syndrome and in Healthy Subjects

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Procedure: Osteopathic manipulative treatment
* Procedure: sham comparator


Participation Criteria
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Eligibility Criteria
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Obstructive sleep apnea syndrome patient: 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 Complete nasal obstruction 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 Patients treated with Selective Serotonin Reuptake Inhibitor Healthy Volunteers Inclusion criteria : Male or Female aged ≥18 and ≤ 40 years No obstructive sleep apnea syndrome Body mass Index <30kg/m2 No chronicle respiratory, neurological, cardiac or able to deteriorate sleep quality disease Low obstructive sleep apnea syndrome probability measured with Berlin Scale Exclusion criteria : Pregnant or lactating women Participating to another trial Acute infectious disease of upper respiratory airway tract at inclusion Complete nasal obstruction Facial neuralgia at inclusion allergy to latex dental extraction within 15 days before inclusion pharyngeal surgery in the past incapable adult patients treated background treatment

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic manipulative treatment<br>Osteopathic compression of pterygopalatine node | Procedure: Osteopathic manipulative treatment<br>* Osteopathic compression of pterygopalatine node<br>|
| Sham Comparator: Sham comparator<br>sham Osteopathic pterygopalatine node compression | Procedure: sham comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharyngeal sensitivity test |  | 30 min | 
| Determination of pharyngeal critical pressure |  | 24 hours | 
| Daily clinical symptoms of osa |  | 7 days | 
| Pharyngeal sensitivity test |  | 24 hours | 
| Determination of pharyngeal critical pressure |  | 30 min | 
| Inspiratory nasal pic flow |  | 30 min | 
| Inspiratory nasal pic flow |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathy, Sleep Apnea Syndromes, Obstructive Sleep Apnea, Pcrit, Polysomnography