Status:
COMPLETED
Osteopathy and Obstructive Sleep Apnea Syndrome II
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01822743
Start Date
January 1 2012
End Date
March 1 2014
Last Update
January 25 2022
Active Locations (1)
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1
Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Paris, France, 75013