Osteopathy and Obstructive Sleep Apnea Syndrome II

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01822743

Acronym

OSTEOSAOSII

Enrollment

Registered

2013-04-02

Start date

2012-01-31

Completion date

2014-03-31

Last updated

2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Osteopathy, Sleep Apnea Syndromes, Obstructive Sleep Apnea, Pcrit, Polysomnography

Brief summary

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

Detailed 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.

Interventions

PROCEDUREOsteopathic manipulative treatment

Osteopathic compression of pterygopalatine node

PROCEDUREsham comparator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Apnea-hypopnea index	24 hours

Secondary

Measure	Time frame
Pharyngeal sensitivity test	30 min
Determination of pharyngeal critical pressure	24 hours
Daily clinical symptoms of osa	7 days
Inspiratory nasal pic flow	30 min

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026