NCT05432908

Brief Summary

To verify the effect of orofacial myofunctional therapy in patients with OSA during the use of CPAP with a nasal mask, on the frequency and leak flow. In addition, the impact on mouth opening frequency, sleep quality, perception of excessive daytime sleepiness, and CPAP adherence will be evaluated.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

July 28, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

3.9 years

First QC Date

May 3, 2022

Last Update Submit

April 8, 2024

Conditions

OSAApnea+Hypopnea

Keywords

Orofacial Myofunctional TherapyOropharyngeal exercisesCPAPNasal maskAir leakSleep apnea

Outcome Measures

Primary Outcomes (1)

  • Effect of Orofacial Myofunctional Therapy on mouth air leak

    The reduction of mouth air leak (L/min) in PSG recordings post Orofacial Myofunctional Therapy

    3 months

Secondary Outcomes (4)

  • Effect of Orofacial Myofunctional Therapy on the leak in CPAP report

    3 months

  • Effect of Orofacial Myofunctional Therapy on the adherence to CPAP

    3 months

  • Effect of Orofacial Myofunctional Therapy on the Pittsburgh Sleep Quality Index score

    3 months

  • Effect of Orofacial Myofunctional Therapy on the Epworth Sleepiness Scale score

    3 months

Study Arms (1)

Orofacial exercises and oropharyngeal functions

EXPERIMENTAL

Orofacial exercises and oropharyngeal functions.

Behavioral: Orofacial exercises and oropharyngeal functions

Interventions

Orofacial exercises and oropharyngeal functionsBEHAVIORAL

Oropharyngeal exercises (derived from speech-language pathology) to the tongue and facial muscles exercises as well stomatognathic functions.

Orofacial exercises and oropharyngeal functions

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of OSA (AHI\>15 events/h) on use of CPAP (\>3 months) with suspect mouth leak as observed by the complaint of morning dry mouth and or CPAP report indicating an excessive air leak

You may not qualify if:

  • Central Sleep Apnea, oxygen dependent, COPD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundação Zerbini - Instituto do Coração (InCor)

São Paulo, São Paulo, 054039000, Brazil

Location

Related Publications (5)

  • Lebret M, Martinot JB, Arnol N, Zerillo D, Tamisier R, Pepin JL, Borel JC. Factors Contributing to Unintentional Leak During CPAP Treatment: A Systematic Review. Chest. 2017 Mar;151(3):707-719. doi: 10.1016/j.chest.2016.11.049. Epub 2016 Dec 14.

    PMID: 27986462BACKGROUND

  • Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652.

    PMID: 25348130BACKGROUND

  • Valentin A, Subramanian S, Quan SF, Berry RB, Parthasarathy S. Air leak is associated with poor adherence to autoPAP therapy. Sleep. 2011 Jun 1;34(6):801-6. doi: 10.5665/SLEEP.1054.

    PMID: 21629369BACKGROUND

  • Lebret M, Arnol N, Martinot JB, Lambert L, Tamisier R, Pepin JL, Borel JC. Determinants of Unintentional Leaks During CPAP Treatment in OSA. Chest. 2018 Apr;153(4):834-842. doi: 10.1016/j.chest.2017.08.017. Epub 2017 Aug 26.

    PMID: 28847549BACKGROUND

  • Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.

    PMID: 33451313BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Geraldo Lorenzi-Filho, PhD

    Hospital das Clínicas HCFMUSP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2022

First Posted

June 27, 2022

Study Start

July 28, 2017

Primary Completion

June 30, 2021

Study Completion

July 1, 2021

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)