Clinical trial NCT01822743: Osteopathy and Obstructive Sleep Apnea Syndrome II
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Osteopathy
Sleep Apnea Syndromes
Obstructive Sleep Apnea
Pcrit
Polysomnography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Apnea-hypopnea index
timeFrame: 24 hours
Secondary outcomes:
measure: Pharyngeal sensitivity test
timeFrame: 30 min
measure: Determination of pharyngeal critical pressure
timeFrame: 24 hours
measure: Daily clinical symptoms of osa
timeFrame: 7 days
measure: Pharyngeal sensitivity test
timeFrame: 24 hours
measure: Determination of pharyngeal critical pressure
timeFrame: 30 min
measure: Inspiratory nasal pic flow
timeFrame: 30 min
measure: Inspiratory nasal pic flow
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Study officials:
affiliation: APHP
name: Valérie Attali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: https://www.mdpi.com/1421774