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Osteopathy and Obstructive Sleep Apnea Syndrome II (OSTEOSAOSII)

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
sham comparator
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Osteopathy, Sleep Apnea Syndromes, Obstructive Sleep Apnea, Pcrit, Polysomnography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Service des pathologies du sommeil, Pitié-Salpêtrière hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Osteopathic manipulative treatment

Sham comparator

Arm Description

Osteopathic compression of pterygopalatine node

sham Osteopathic pterygopalatine node compression

Outcomes

Primary Outcome Measures

Apnea-hypopnea index

Secondary Outcome Measures

Pharyngeal sensitivity test
Determination of pharyngeal critical pressure
Daily clinical symptoms of osa
Pharyngeal sensitivity test
Determination of pharyngeal critical pressure
Inspiratory nasal pic flow
Inspiratory nasal pic flow

Full Information

First Posted
March 28, 2013
Last Updated
January 10, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01822743
Brief Title
Osteopathy and Obstructive Sleep Apnea Syndrome II
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Osteopathy, Sleep Apnea Syndromes, Obstructive Sleep Apnea, Pcrit, Polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic manipulative treatment
Arm Type
Experimental
Arm Description
Osteopathic compression of pterygopalatine node
Arm Title
Sham comparator
Arm Type
Sham Comparator
Arm Description
sham Osteopathic pterygopalatine node compression
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
Osteopathic compression of pterygopalatine node
Intervention Type
Procedure
Intervention Name(s)
sham comparator
Primary Outcome Measure Information:
Title
Apnea-hypopnea index
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pharyngeal sensitivity test
Time Frame
30 min
Title
Determination of pharyngeal critical pressure
Time Frame
24 hours
Title
Daily clinical symptoms of osa
Time Frame
7 days
Title
Pharyngeal sensitivity test
Time Frame
24 hours
Title
Determination of pharyngeal critical pressure
Time Frame
30 min
Title
Inspiratory nasal pic flow
Time Frame
30 min
Title
Inspiratory nasal pic flow
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Attali, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service des pathologies du sommeil, Pitié-Salpêtrière hospital
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
Citation
https://www.mdpi.com/1421774
Results Reference
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Osteopathy and Obstructive Sleep Apnea Syndrome II

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