OSANCT05432908
Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP
A study testing Orofacial exercises and oropharyngeal functions in people with OSA and Apnea+Hypopnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA, Apnea+Hypopnea
- What is being tested?
- Orofacial exercises and oropharyngeal functions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jul 2017to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Central Sleep Apnea, oxygen dependent, COPD.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fundação Zerbini - Instituto do Coração (InCor)
São Paulo, São Paulo, 054039000
About this study
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)
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.
Read the 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.
- Conditions
- OSA, Apnea+Hypopnea
- Being tested
- Orofacial exercises and oropharyngeal functions
- Keywords
- Orofacial Myofunctional Therapy, Oropharyngeal exercises, CPAP, Nasal mask, Air leak, Sleep apnea
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orofacial exercises and oropharyngeal functionsBehavioural
Oropharyngeal exercises (derived from speech-language pathology) to the tongue and facial muscles exercises as well stomatognathic functions.
| Study group | Role | What they receive |
|---|---|---|
| Orofacial exercises and oropharyngeal functions | Experimental | Orofacial exercises and oropharyngeal functions. Receives: Behavioral: Orofacial exercises and oropharyngeal functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Orofacial Myofunctional Therapy on mouth air leak
The reduction of mouth air leak (L/min) in PSG recordings post Orofacial Myofunctional Therapy
Measured: 3 months
Secondary outcomes (4)
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start28 Jul 2017
- Primary completion30 Jun 2021
- Study completion1 Jul 2021
Why it stopped: Difficulties to recruit due to COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geraldo Lorenzi Filho, University of Sao Paulo General Hospital
- Investigators
- Geraldo Lorenzi-Filho, PhD, Principal investigator, Hospital das Clínicas HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432908
- Sponsor's protocol ID
- 4525/17/025
- Status last verified
- Apr 2024
- First submitted
- 3 May 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27986462Camacho 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.
PubMed 25348130Valentin 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.
PubMed 21629369Lebret 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.
PubMed 28847549Rotty 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.
PubMed 33451313
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05432908
- Acronym / sponsor ID
- 4525/17/025
- Conditions
- OSA, Apnea+Hypopnea
- Keywords
- Orofacial Myofunctional Therapy, Oropharyngeal exercises, CPAP, Nasal mask, Air leak, Sleep apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties to recruit due to COVID pandemic
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orofacial exercises and oropharyngeal functions | Experimental | Behavioral: Orofacial exercises and oropharyngeal functionsOrofacial exercises and oropharyngeal functions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Central Sleep Apnea, oxygen dependent, COPD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orofacial exercises and oropharyngeal functionsOropharyngeal exercises (derived from speech-language pathology) to the tongue and facial muscles exercises as well stomatognathic functions. | Behavioural | Orofacial exercises and oropharyngeal functions |
Primary outcome
Effect of Orofacial Myofunctional Therapy on mouth air leak
Time frame: 3 months
The reduction of mouth air leak (L/min) in PSG recordings post Orofacial Myofunctional Therapy
4 secondary outcomes
Effect of Orofacial Myofunctional Therapy on the leak in CPAP report
Time frame: 3 months
Effect of Orofacial Myofunctional Therapy on the adherence to CPAP
Time frame: 3 months
Effect of Orofacial Myofunctional Therapy on the Pittsburgh Sleep Quality Index score
Time frame: 3 months
Effect of Orofacial Myofunctional Therapy on the Epworth Sleepiness Scale score
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Difficulties to recruit due to COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 27986462Lebret 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.
- Background: PubMed 25348130Camacho 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.
- Background: PubMed 21629369Valentin 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.
- Background: PubMed 28847549Lebret 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.
- Background: PubMed 33451313Rotty 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.
- Individual participant dataSharing planned: No
Related trials for OSA
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldo Lorenzi-Filho, PhD principal investigator
Hospital das Clínicas HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orofacial exercises and oropharyngeal functions in people with OSA and Apnea+Hypopnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties to recruit due to COVID pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Orofacial Myofunctional Therapy on mouth air leak (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05432908, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.