Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
52 participants
INTERVENTIONAL
2012-01-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Osteopathic manipulative treatment
Osteopathic compression of pterygopalatine node
Osteopathic manipulative treatment
Osteopathic compression of pterygopalatine node
Sham comparator
sham Osteopathic pterygopalatine node compression
sham comparator
Interventions
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Osteopathic manipulative treatment
Osteopathic compression of pterygopalatine node
sham comparator
Eligibility Criteria
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Inclusion Criteria
* Obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour
* Body mass Index \<40kg/m2
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Valérie Attali, MD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Paris, , France
Countries
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References
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https://www.mdpi.com/1421774
Other Identifiers
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P111007
Identifier Type: -
Identifier Source: org_study_id
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