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CompletedNCT01822743OSTEOSAOSIIUpdated Jan 25, 2022

Osteopathy and Obstructive Sleep Apnea Syndrome II

A Phase 3 interventional study of Osteopathic manipulative treatment and sham comparator in Obstructive Sleep Apnea Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea Syndrome

Keywords

  • Osteopathy
  • Sleep Apnea Syndromes
  • Obstructive Sleep Apnea
  • Pcrit
  • Polysomnography
03

In context

Apnea

1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's enrollment of 52 is close to the median of 51 across 966 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Osteopathic manipulative treatment

    Osteopathic compression of pterygopalatine node

    Procedure: Osteopathic manipulative treatment

  • Sham comparator
    Sham comparator

    sham Osteopathic pterygopalatine node compression

    Procedure: sham comparator

Interventions

  • ProcedureOsteopathic manipulative treatment

    Osteopathic compression of pterygopalatine node

  • Proceduresham comparator
06

What researchers measure

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

07

Study locations

1 site
  • Service des pathologies du sommeil, Pitié-Salpêtrière hospital
    Paris, 75013, France
08

References and documents

Publications

  • https://www.mdpi.com/1421774
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01822743
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 2, 2013
Start date
Jan 2012
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Jan 25, 2022

Study contacts

Valérie Attali, MD
principal investigator · APHP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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