Swallowing in OSA & CPAP Intolerance

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Denise Dewald
Study ID
NCT06786117
Status
Enrolling By Invitation

Conditions

  • Healthy
  • Sleep Apnea, Obstructive

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • SLP swallowing exercises — OTHER
    Clinical speech language pathologists will provide standard exercises based on the abnormalities seen on the modified barium swallow. Exercises are expected to include the effortful swallow, the Mendelsohn maneuver, expiratory muscle strength training with the EMST-150, supraglottic swallow, super supraglottic swallow, chin tuck against resistance isokinetic exercise, chin tuck against resistance isometric exercise, Masako maneuver, Shaker isometric head lift exercise, Shaker isokinetic head lift exercise, Falsetto high pitch glide exercise, tongue press exercise
  • myofunctional exercises — OTHER
    Participants will get a variety of exercises aimed at improving bolus formation, strengthening the seal of the soft palate with the tongue, and habituating nasal breathing. There will also be exercises aimed at stabilizing the epiglottis and strengthening the muscles supporting the lateral pharyngeal walls. Expiratory muscle strength training with the EMST-150 will also be done.

Study Details

This study has two parts: an observational part and an interventional part. The goal of the observational part of the study is to look for variations in swallowing in adults with obstructive sleep apnea (OSA) and in adults who don't snore. The main questions it aims to answer are: * Are there differences in swallowing between people with OSA and people who don't snore? * Are there differences in swallowing between people with OSA who do well with continuous positive airway pressure (CPAP) therapy and those who struggle with CPAP? This may help us better understand what causes OSA, which may help us develop alternate ways to treat or even prevent OSA. It may also help us improve care for people with OSA who struggle with CPAP. Participants will be aged 40-60 years, except women up to the age of 70 will be included in the healthy control (non-snorer) group. Participants will: * Undergo a type of x-ray study called a modified barium swallow study (MBS) * Come to MetroHealth Medical Center for a measurement visit to: * assess the strength of their tongue, lips, and cheeks * assess the strength of their breathing muscles * assess for restrictions in tongue mobility (tongue ties) * observe their resting breathing * take photos of their mouth and posture * take videos of them drinking and eating * Complete some questionnaires * For successful CPAP users: we will download data from the chip in their CPAP device * Do a home sleep test (except for successful CPAP users who have had a recent in-lab sleep test) The goal of the interventional part of the study is to test swallowing exercises in people ages 40-60 years with OSA who struggle with CPAP. The main question it aims to answer is: • Can swallowing exercises help people who struggle with CPAP sleep better with CPAP? Participants will: * Try to use CPAP for 2 weeks with individualized support * Do all the investigations listed in the observational part of the study * Do one or two courses of swallowing exercises, each of which would last 7 weeks. Participants will be asked to do daily exercises; exercises will take 20-30 minutes to perform. * Try to use CPAP for 2 weeks after the course of exercises * Repeat the investigations listed in the observational part of the study to see if changes occurred with the swallowing exercise intervention.

Key Dates

Start date
Mar 5, 2025
Status verified
Jan 2025
Primary completion
Dec 30, 2026
Completion
Jan 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Healthy airways group
    Participants will get a home sleep test to verify that sleep disordered breathing is not present. They will do a modified barium study (MBS) and a measurement visit to assess oral and respiratory muscle strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture. They will also fill out some questionnaires.
  • No Intervention: Successful CPAP user
    Participants who do well will CPAP will do a modified barium study (MBS) and a measurement visit to assess oral and respiratory muscle strength, tongue mobility, nasal airflow, eating and drinking, dental and facial form, and posture. They will also fill out some questionnaires. Participants will also provide their CPAP data on an SD card. Participants will also do a home sleep test if there is no recent sleep study available.
  • Experimental: CPAP intolerant - SLP exercises only
    CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and a measurement visit. During the measurement visit their oral and respiratory strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out questionnaires. Participants with abnormalities on their MBS will get a 7-week course of standard swallowing exercises, with weekly in-person visits with a speech pathologist. They will be expected to do daily exercises (which will take 20-30 minutes). They will then try to use CPAP for two weeks to see if they are able to use CPAP better. If they do well with CPAP or are still struggling with CPAP but do not want to continue onto the myofunctional therapy arm, they will do an MBS, home sleep test, questionnaires, and the measurement visit again.
  • Experimental: CPAP intolerant - OMT exercises only
    CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and also a measurement visit. During the measurement visit their oral and respiratory strength, tongue mobility, nasal airflow, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out some questionnaires. CPAP intolerant participants without abnormalities on their MBS will get oral myofunctional therapy (OMT) exercises. The course of exercises will take 7 weeks to complete, with weekly video follow up visits. The exercises will take 20-30 minutes to do over the course of the day. After completing the 7-week course, participants will repeat the home sleep test, modified barium study, questionnaires, and measurement visit, and will once more try using CPAP for two weeks to see if they are able to use CPAP better.
  • Experimental: CPAP intolerant - SLP and OMT
    CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and also a measurement visit. During the measurement visit their oral and respiratory strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out questionnaires. Participants with abnormalities on their MBS will get standard swallowing exercises based on the abnormalities. They will then try using CPAP for two weeks. If they do not improve their CPAP tolerance with standard swallowing exercises, they will do a course of myofunctional therapy exercises. Both courses will be 7 weeks long, with daily exercises to do at home lasting 20-30 min. They will then repeat the home sleep test, MBS, questionnaires, and measurement visit, and will try using CPAP for two weeks to see if they can use CPAP better.

Primary Outcome Measure

Prevalence of premature spillage in participants with OSA who are CPAP intolerant vs participants who are successful nasal CPAP users or who have healthy airways [ Time Frame: at the time of MBS (within 2-4 weeks of study enrollment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44109-

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By research site
MetroHealth Medical Center· Cleveland, OH

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