Osteopathy and Obstructive Sleep Apnea Syndrome II

Obstructive Sleep Apnea Syndrome Clinical Trial

— OSTEOSAOSII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822743
• Other study ID #: P111007
• Status: Completed
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).

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 pharyngeal collapsibility in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Osteopathic manipulative treatment
Osteopathic compression of pterygopalatine node
• sham comparator

Locations

Country	Name	City	State
France	Service des pathologies du sommeil, Pitié-Salpêtrière hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

https://www.mdpi.com/1421774

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index		24 hours
Secondary	Pharyngeal sensitivity test		30 min
Secondary	Determination of pharyngeal critical pressure		24 hours
Secondary	Daily clinical symptoms of osa		7 days
Secondary	Pharyngeal sensitivity test		24 hours
Secondary	Determination of pharyngeal critical pressure		30 min
Secondary	Inspiratory nasal pic flow		30 min
Secondary	Inspiratory nasal pic flow		24 hours