Back to resultsOsteopathy and Obstructive Sleep Apnea Syndrome
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
osteopathic compression of Pterygopalatine node
Sponsored by
About this trial
This is an interventional basic science trial for Obstructive Sleep Apnea Syndrome focused on measuring osteopathy
Eligibility Criteria
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
Sites / Locations
- Pathologies Du Sommeil Pitie Salpetriere
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
active osteopathic compression
placebo osteopathic compression
Arm Description
osteopathic compression of Pterygopalatine node
placebo osteopathic compression
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
symptoms
OSA symptoms
adverse events
clinical evaluation of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01193738
Brief Title
Osteopathy and Obstructive Sleep Apnea Syndrome
Official Title
a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Valerie Attali
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).
Detailed Description
Osteopathic compression will be compared to a placebo manoeuvre. Efficacy will be assessed by measuring pharyngeal collapsibility
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
osteopathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active osteopathic compression
Arm Type
Active Comparator
Arm Description
osteopathic compression of Pterygopalatine node
Arm Title
placebo osteopathic compression
Arm Type
Placebo Comparator
Arm Description
placebo osteopathic compression
Intervention Type
Procedure
Intervention Name(s)
osteopathic compression of Pterygopalatine node
Intervention Description
osteopathic compression of Pterygopalatine node
Primary Outcome Measure Information:
Title
pharyngeal critical pressure
Description
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
Time Frame
30 minutes after osteopathic compression
Secondary Outcome Measure Information:
Title
pharyngeal critical pressure
Description
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
Time Frame
48 hours
Title
symptoms
Description
OSA symptoms
Time Frame
48 hours
Title
adverse events
Description
clinical evaluation of adverse events
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
valerie attali, MD
Organizational Affiliation
Federation des pathologies du sommeil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pathologies Du Sommeil Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29262824
Citation
Jacq O, Arnulf I, Similowski T, Attali V. Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study. BMC Complement Altern Med. 2017 Dec 20;17(1):546. doi: 10.1186/s12906-017-2053-0.
Results Reference
derived
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Osteopathy and Obstructive Sleep Apnea Syndrome
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