Swallowing in OSA & CPAP Intolerance

Summary

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.

Conditions

• Sleep Apnea, Obstructive
• Healthy

Interventions

OTHER

SLP swallowing exercises

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

OTHER

myofunctional exercises

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.

Sponsors & Collaborators

• American Academy of Sleep Medicine

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• MetroHealth Medical Center

  collaborator OTHER

• Denise Dewald

  lead OTHER

Principal Investigators

• Denise Dewald, MD · MetroHealth Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-05

Primary Completion

2026-12-30

Completion

2028-01-30

Countries

• United States

Study Locations