Osteopathy and Obstructive Sleep Apnea Syndrome
a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.
2 other identifiers
interventional
10
1 country
1
Brief Summary
The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedAugust 11, 2015
August 1, 2015
1.2 years
September 1, 2010
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
30 minutes after osteopathic compression
Secondary Outcomes (3)
pharyngeal critical pressure
48 hours
symptoms
48 hours
adverse events
48 hours
Study Arms (2)
active osteopathic compression
ACTIVE COMPARATORosteopathic compression of Pterygopalatine node
placebo osteopathic compression
PLACEBO COMPARATORplacebo osteopathic compression
Interventions
osteopathic compression of Pterygopalatine node
Eligibility Criteria
You may qualify if:
- Male or Female aged 18 years or more
- obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour
- Body mass Index \<40kg/m2
You may not qualify if:
- pregnant or lactating women
- participating to another trial
- patients not able to stop treatment for OSA within one week before each visit
- allergy to latex
- pharyngeal surgery in the past
- incapable adult
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valerie Attalilead
Study Sites (1)
Pathologies Du Sommeil Pitie Salpetriere
Paris, 75013, France
Related Publications (1)
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.
PMID: 29262824DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
valerie attali, MD
Federation des pathologies du sommeil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 2, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
August 11, 2015
Record last verified: 2015-08