We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Osteopathy and Obstructive Sleep Apnea Syndrome II (OSTEOSAOSII)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822743
First Posted: April 2, 2013
Last Update Posted: June 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).

Condition Intervention Phase
Obstructive Sleep Apnea Syndrome Procedure: Osteopathic manipulative treatment Procedure: sham comparator Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Apnea-hypopnea index [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Pharyngeal sensitivity test [ Time Frame: 30 min ]
  • Determination of pharyngeal critical pressure [ Time Frame: 24 hours ]
  • Daily clinical symptoms of osa [ Time Frame: 7 days ]
  • Pharyngeal sensitivity test [ Time Frame: 24 hours ]
  • Determination of pharyngeal critical pressure [ Time Frame: 30 min ]
  • Inspiratory nasal pic flow [ Time Frame: 30 min ]
  • Inspiratory nasal pic flow [ Time Frame: 24 hours ]

Enrollment: 52
Study Start Date: January 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osteopathic manipulative treatment
Osteopathic compression of pterygopalatine node
Procedure: Osteopathic manipulative treatment
Osteopathic compression of pterygopalatine node
Sham Comparator: Sham comparator
sham Osteopathic pterygopalatine node compression
Procedure: sham comparator

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822743


Locations
France
Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Valérie Attali, MD APHP
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01822743     History of Changes
Other Study ID Numbers: P111007
First Submitted: March 28, 2013
First Posted: April 2, 2013
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Osteopathy
Sleep Apnea Syndromes
Obstructive Sleep Apnea
Pcrit
Polysomnography

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases