NCT01822743

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 25, 2022

Status Verified

June 1, 2014

Enrollment Period

2.2 years

First QC Date

March 28, 2013

Last Update Submit

January 10, 2022

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

OsteopathySleep Apnea SyndromesObstructive Sleep ApneaPcritPolysomnography

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index

    24 hours

Secondary Outcomes (7)

  • Pharyngeal sensitivity test

    30 min

  • Determination of pharyngeal critical pressure

    24 hours

  • Daily clinical symptoms of osa

    7 days

  • Pharyngeal sensitivity test

    24 hours

  • Determination of pharyngeal critical pressure

    30 min

  • +2 more secondary outcomes

Study Arms (2)

Osteopathic manipulative treatment

EXPERIMENTAL

Osteopathic compression of pterygopalatine node

Procedure: Osteopathic manipulative treatment

Sham comparator

SHAM COMPARATOR

sham Osteopathic pterygopalatine node compression

Procedure: sham comparator

Interventions

Osteopathic manipulative treatmentPROCEDURE

Osteopathic compression of pterygopalatine node

Osteopathic manipulative treatment
sham comparatorPROCEDURE
Sham comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female aged 18 years or more
  • Obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour
  • Body mass Index \<40kg/m2

You may not qualify if:

  • Pregnant or lactating women
  • Participating to another trial
  • Complete nasal obstruction
  • Patients not able to stop treatment for OSA within one week before each visit
  • Allergy to latex
  • Pharyngeal surgery in the past
  • Incapable adult
  • Patients treated with Selective Serotonin Reuptake Inhibitor
  • Healthy Volunteers
  • 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
  • Pregnant or lactating women
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des pathologies du sommeil, Pitié-Salpêtrière hospital

Paris, 75013, France

Location

Related Publications (1)

  • https://www.mdpi.com/1421774

    RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Valérie Attali, MD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 2, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 25, 2022

Record last verified: 2014-06

Locations

FR(1)