Osteopathy and Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193738
• Other study ID #: 2009-A01373-54
• Secondary ID: ADOREP 2009-068
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: August 10, 2015
• Start date: September 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2015
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).

Description:

Osteopathic compression will be compared to a placebo manoeuvre. Efficacy will be assessed by measuring pharyngeal collapsibility

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Procedure:
• osteopathic compression of Pterygopalatine node
osteopathic compression of Pterygopalatine node

Locations

Country	Name	City	State
France	Pathologies Du Sommeil Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Valerie Attali

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	48 hours	No
Secondary	symptoms	OSA symptoms	48 hours	No
Secondary	adverse events	clinical evaluation of adverse events	48 hours	Yes