Effect of Myofunctional Therapy on OSA
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|ClinicalTrials.gov Identifier: NCT04608552|
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : February 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Behavioral: OMT Exercises Behavioral: Nasal Breathing Exercises Other: Use of Nasal Lavage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea|
|Actual Study Start Date :||August 2, 2021|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||September 30, 2024|
Active Comparator: Active Myofunctional Therapy
Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.
Behavioral: OMT Exercises
Oral and oropharyngeal exercises
Sham Comparator: Inactive Myofunctional Therapy
Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day.
Behavioral: Nasal Breathing Exercises
Nasal breathing exercises each week
Other: Use of Nasal Lavage
Use of nasal lavage with application of 10ml of saline in each nostril two times per day
- Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity) [ Time Frame: 3 months and 6 months ]Compare the change in AHI between OMT and inactive OMT groups over the follow-up time points. Higher AHI scores indicate increase sleep apnea disease severity.
- Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning) [ Time Frame: 3 months and 6 months ]Compare the change in FOSQ between OMT and inactive OMT groups over the follow-up time points. Higher FOSQ scores indicate improved levels of daytime functioning.
- Change in Epworth Sleepiness Score (ESS; measure of sleepiness) [ Time Frame: 3 months and 6 months ]Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels.
- Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality) [ Time Frame: 3 months and 6 months ]Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608552
|Contact: Tania Zamora, MS||(858) firstname.lastname@example.org|
|Contact: Carl J Stepnowsky, Jr., PhD||(858) 642-1240||Carl.Stepnowsky@va.gov|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Tania Zamora, MS 858-642-3269 email@example.com|
|Contact: Carl J Stepnowsky, Jr., PhD (858) 642-1240 Carl.Stepnowsky@va.gov|
|Principal Investigator: Carl J Stepnowsky, Jr., PhD|
|Principal Investigator:||Carl J Stepnowsky, Jr., PhD||VA San Diego Healthcare System, San Diego, CA|