Osteopathy and Obstructive Sleep Apnea Syndrome II (OSTEOSAOSII)

This study is currently recruiting participants.
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01822743
First received: March 28, 2013
Last updated: November 12, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharyngeal sensitivity test [ Time Frame: 30 min ] [ Designated as safety issue: No ]
  • Determination of pharyngeal critical pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Daily clinical symptoms of osa [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Pharyngeal sensitivity test [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Determination of pharyngeal critical pressure [ Time Frame: 30 min ] [ Designated as safety issue: No ]
  • Inspiratory nasal pic flow [ Time Frame: 30 min ] [ Designated as safety issue: No ]
  • Inspiratory nasal pic flow [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822743

Locations
France
Service des pathologies du sommeil, Pitié-Salpêtrière hospital Recruiting
Paris, France, 75013
Contact: Valérie Attali, MD    + 33 1 42 16 77 23    valerie.attali@psl.aphp.fr   
Contact: Thomas Similowski, MD, PhD    + 33 1 42 16 77 52    thomas.similowski@psl.aphp.fr   
Principal Investigator: Valérie Attali, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Valérie Attali, MD APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01822743     History of Changes
Other Study ID Numbers: P111007
Study First Received: March 28, 2013
Last Updated: November 12, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 15, 2014