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Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP

Primary Purpose

OSA, Apnea+Hypopnea

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orofacial exercises and oropharyngeal functions
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OSA focused on measuring Orofacial Myofunctional Therapy, Oropharyngeal exercises, CPAP, Nasal mask, Air leak, Sleep apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• 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

Exclusion Criteria:

  • Central Sleep Apnea, oxygen dependent, COPD.

Sites / Locations

  • Fundação Zerbini - Instituto do Coração (InCor)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orofacial exercises and oropharyngeal functions

Arm Description

Orofacial exercises and oropharyngeal functions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of Orofacial Myofunctional Therapy on the leak in CPAP report
Effect of Orofacial Myofunctional Therapy on the mean value of leak in liters per minute in the CPAP report
Effect of Orofacial Myofunctional Therapy on the adherence to CPAP
Effect of Orofacial Myofunctional Therapy on the mean value of hours of use in the CPAP report
Effect of Orofacial Myofunctional Therapy on the Pittsburgh Sleep Quality Index score
The reduction in questionnaire scores on Pittsburgh Sleep Quality Index, ranging from 0 to 21 (referred to as the global score), with the higher total score indicating worse sleep quality, post-Orofacial Myofunctional Therapy
Effect of Orofacial Myofunctional Therapy on the Epworth Sleepiness Scale score
The reduction in questionnaire scores on the perception of excessive daytime somnolence (Epworth Sleepiness Scale, score ranging from 0 to 24, with a total score ≥10 representing excessive daytime sleepiness) post-Orofacial Myofunctional Therapy

Full Information

First Posted
May 3, 2022
Last Updated
June 22, 2022
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05432908
Brief Title
Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP
Official Title
Effect of Orofacial Myofunctional Therapy on Unintentional Air Leak From the Oral Cavity in Patients With Obstructive Sleep Apnea Treated With Continuous Positive Upper Airway Pressure (CPAP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The use of continuous positive airway pressure (CPAP) with a nasal mask during sleep is the gold standard treatment for moderate to severe obstructive sleep apnea (OSA). However, low adherence to CPAP is the main limiting factor in clinical practice. Recent studies suggest that unintentional air leak through the mouth contributes significantly to poor adherence to CPAP. Orofacial myofunctional therapy (OMT) is effective for treating mild to moderate OSA and has not been tested in patients with mouth air leaks. OSA patients using nasal CPAP and mouth air leaks will be recruited and will use the standard CPAP model and nasal mask during the first and last week of the study to record adherence and home leak. Patients will be treated by performing daily (3 times a day) orofacial myofunctional exercises aimed at strengthening the muscles of the oral cavity. Exercises will be supervised weekly for 3 months. All patients will undergo at the beginning and end of treatment: polysomnography with CPAP and nasal mask, speech-language pathology assessment adequated for OSA (scores ranging from 0 to 241, with higher values indicating greater dysfunction), quality of life questionnaire, and nasosinusal symptoms (SNOT -22), sleep quality (Pittsburgh) and sleepiness (Epworth). Polysomnography will include a pneumotachograph (Hans Rudolph) in the CPAP circuit to record flow and a magnetic jaw movement sensor (Brizzy) to record the episodes of mouth opening. The mouth air leak episodes were considered when they exceeded 20% above baseline (intentional leak with the mask fitted and mouth closed at the beginning of the PSG examination with CPAP) for a minimum of 10 seconds. Leaks ending with arousal or full awakening were considered arousal or full awakening associated with mouth air leak. Mouth opening during the leak episodes was determined by the difference between the amplitude at the end of the leak and the amplitude during the leak. Our hypothesis is that the orofacial myofunctional therapy will reduce mouth leakage in OSA patients treated with CPAP and nasal mask.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA, Apnea+Hypopnea
Keywords
Orofacial Myofunctional Therapy, Oropharyngeal exercises, CPAP, Nasal mask, Air leak, Sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orofacial exercises and oropharyngeal functions
Arm Type
Experimental
Arm Description
Orofacial exercises and oropharyngeal functions.
Intervention Type
Behavioral
Intervention Name(s)
Orofacial exercises and oropharyngeal functions
Intervention Description
Oropharyngeal exercises (derived from speech-language pathology) to the tongue and facial muscles exercises as well stomatognathic functions.
Primary Outcome Measure Information:
Title
Effect of Orofacial Myofunctional Therapy on mouth air leak
Description
The reduction of mouth air leak (L/min) in PSG recordings post Orofacial Myofunctional Therapy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effect of Orofacial Myofunctional Therapy on the leak in CPAP report
Description
Effect of Orofacial Myofunctional Therapy on the mean value of leak in liters per minute in the CPAP report
Time Frame
3 months
Title
Effect of Orofacial Myofunctional Therapy on the adherence to CPAP
Description
Effect of Orofacial Myofunctional Therapy on the mean value of hours of use in the CPAP report
Time Frame
3 months
Title
Effect of Orofacial Myofunctional Therapy on the Pittsburgh Sleep Quality Index score
Description
The reduction in questionnaire scores on Pittsburgh Sleep Quality Index, ranging from 0 to 21 (referred to as the global score), with the higher total score indicating worse sleep quality, post-Orofacial Myofunctional Therapy
Time Frame
3 months
Title
Effect of Orofacial Myofunctional Therapy on the Epworth Sleepiness Scale score
Description
The reduction in questionnaire scores on the perception of excessive daytime somnolence (Epworth Sleepiness Scale, score ranging from 0 to 24, with a total score ≥10 representing excessive daytime sleepiness) post-Orofacial Myofunctional Therapy
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: Central Sleep Apnea, oxygen dependent, COPD.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geraldo Lorenzi-Filho, PhD
Phone
55 11 2661-5486
Email
geraldo.lorenzi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geraldo Lorenzi-Filho, PhD
Organizational Affiliation
Hospital das Clínicas HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundação Zerbini - Instituto do Coração (InCor)
City
São Paulo
State/Province
SP
ZIP/Postal Code
054039000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geraldo Lorenzi-Filho, PhD
Phone
55 11 2661-5486
Email
geraldo.lorenzi@gmail.com
First Name & Middle Initial & Last Name & Degree
Erika Matsumura, MSc
Phone
55 11 2661-5486
Email
eerikamat@gmail.com
First Name & Middle Initial & Last Name & Degree
Geraldo Lorenzi, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27986462
Citation
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.
Results Reference
background
PubMed Identifier
25348130
Citation
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.
Results Reference
background
PubMed Identifier
21629369
Citation
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.
Results Reference
background
PubMed Identifier
28847549
Citation
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.
Results Reference
background
PubMed Identifier
33451313
Citation
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.
Results Reference
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Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP

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