ClinicalTrials.gov
ClinicalTrials.gov Menu

Osteopathy and Obstructive Sleep Apnea Syndrome II (OSTEOSAOSII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01822743
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

March 28, 2013
April 2, 2013
June 16, 2014
January 2012
March 2014   (Final data collection date for primary outcome measure)
Apnea-hypopnea index [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01822743 on ClinicalTrials.gov Archive Site
  • Pharyngeal sensitivity test [ Time Frame: 30 min ]
  • Determination of pharyngeal critical pressure [ Time Frame: 24 hours ]
  • Daily clinical symptoms of osa [ Time Frame: 7 days ]
  • Pharyngeal sensitivity test [ Time Frame: 24 hours ]
  • Determination of pharyngeal critical pressure [ Time Frame: 30 min ]
  • Inspiratory nasal pic flow [ Time Frame: 30 min ]
  • Inspiratory nasal pic flow [ Time Frame: 24 hours ]
Same as current
Not Provided
Not Provided
 
Osteopathy and Obstructive Sleep Apnea Syndrome II
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
The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Obstructive Sleep Apnea Syndrome
  • Procedure: Osteopathic manipulative treatment
    Osteopathic compression of pterygopalatine node
  • Procedure: sham comparator
  • Experimental: Osteopathic manipulative treatment
    Osteopathic compression of pterygopalatine node
    Intervention: Procedure: Osteopathic manipulative treatment
  • Sham Comparator: Sham comparator
    sham Osteopathic pterygopalatine node compression
    Intervention: Procedure: sham comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
50
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01822743
P111007
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Valérie Attali, MD APHP
Assistance Publique - Hôpitaux de Paris
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP