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Completed

NCT Number: NCT01822743

Osteopathy and Obstructive Sleep Apnea Syndrome II

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

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service des pathologies du sommeil, Pitié-Salpêtrière hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulative Treatment

Procedure

Osteopathic compression of pterygopalatine node

Sham Comparator

Procedure

Primary outcomes

  1. Apnea-hypopnea index

    Time frame: 24 hours

Secondary outcomes

  1. Pharyngeal sensitivity test

    Time frame: 30 min

  2. Determination of pharyngeal critical pressure

    Time frame: 24 hours

  3. Daily clinical symptoms of osa

    Time frame: 7 days

  4. Pharyngeal sensitivity test

    Time frame: 24 hours

  5. Determination of pharyngeal critical pressure

    Time frame: 30 min

  6. Inspiratory nasal pic flow

    Time frame: 30 min

  7. Inspiratory nasal pic flow

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: OSTEOSAOSII

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2013
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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