Osteopathy and Obstructive Sleep Apnea Syndrome II (OSTEOSAOSII)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Procedure: Osteopathic manipulative treatment; Procedure: sham comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT01822743

P111007

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Osteopathic manipulative treatment

Experimental group

Description:

Osteopathic compression of pterygopalatine node

Treatment:

Procedure: Osteopathic manipulative treatment

Sham comparator

Sham Comparator group

Description:

sham Osteopathic pterygopalatine node compression

Treatment:

Procedure: sham comparator