Swallowing in OSA & CPAP Intolerance

NCT06786117 | Enrolling By Invitation

• 2 other identifiers: STUDY0000450299-JF-23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

OSA; obstructive sleep apnea; sleep apnea; myofunctional therapy; swallowing exercises; speech language pathology; modified barium swallow; CPAP; CPAP intolerance; CPAP adherence; continuous positive airway pressure; EMST-150; expiratory muscle strength training; respiratory muscle strength; respiratory muscle strength training; non-snorers

Outcome Measures

Primary Outcomes (2)

• 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

  MBS images will be evaluated for premature spillage during oral bolus formation. Comparison of prevalence of premature spillage will be made between study groups.

  at the time of MBS (within 2-4 weeks of study enrollment)

• Effect of swallowing exercise intervention for CPAP intolerance

  The effect of a swallowing exercise intervention on CPAP intolerance will be assessed, as reflected by change in usage from the participants' own pre-treatment CPAP data. The results of the two exercise interventions will be pooled, as the goal is to see if swallowing exercises can improve CPAP tolerance rather than to compare therapies.

  3-7 months after enrollment

Secondary Outcomes (69)

• Baseline length of the oropharyngeal seal during bolus formation in the modified barium swallow study (MBS)

  at the time of MBS (within 2-4 weeks of study enrollment)

• Baseline breathing route during wakefulness as assessed by MBS

  at the time of MBS (within 2-4 weeks of study enrollment)

• Baseline tongue position as observed during nasal breathing during MBS

  at the time of MBS (within 2-4 weeks of study enrollment)

• Baseline soft palate shape as observed during nasal breathing during MBS

  at the time of MBS (within 2-4 weeks of study enrollment)

• Baseline assessment of Tipper- vs Dipper-type oral swallowing

  at the time of MBS (within 2-4 weeks of study enrollment)

Other Outcomes (1)

• Long term outcome of swallowing exercise intervention on average nightly hours of CPAP use (participants with CPAP intolerance only)

  3-15 months after completion of the final exercise intervention (depending on whether participant will need a CPAP device)

Study Arms (5)

Healthy airways group

NO INTERVENTION

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.

Successful CPAP user

NO INTERVENTION

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.

CPAP intolerant - SLP exercises only

EXPERIMENTAL

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.

Other: SLP swallowing exercises

CPAP intolerant - OMT exercises only

EXPERIMENTAL

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.

Other: myofunctional exercises

CPAP intolerant - SLP and OMT

EXPERIMENTAL

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.

Other: SLP swallowing exercises; Other: myofunctional exercises

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

Also known as: speech language pathology exercises, SLP exercises

CPAP intolerant - SLP and OMT; CPAP intolerant - SLP exercises only

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.

Also known as: orofacial myofunctional therapy (OMT), OMT exercises

CPAP intolerant - OMT exercises only; CPAP intolerant - SLP and OMT

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naturally ideal dental occlusion without orthodontic intervention, including successful eruption of wisdom teeth (without significant dental crowding, though minor rotation of less than 4 teeth will be acceptable)
• No sleep-related complaints
• No snoring.
• They should be missing no more than 4 of their natural teeth, and these should have been lost to decay or accident rather than due to crowding. A person whose wisdom teeth came in successfully but were extracted "preventatively" will be eligible for the study.
• Should be getting at least 6 hours of sleep nightly.
• BMI between 18.5 and 35
• Participant will have experienced significant benefits from therapy and have had such benefit since the first night of use. Participant should have no significant sleep complaints when using CPAP.
• Uses CPAP \> 6 hours of nightly use on \> 90% of nights using a nasal mask.
• Residual device AHI \< 5 events/hour.
• Has used CPAP for at least 12 months.
• Symptomatic at diagnosis, with polysomnography (PSG) showing AASM AHI 5-60 and symptoms attributable to OSA, with greater than 75% of the apneas and hypopneas being obstructive in nature. Home sleep apnea testing (HSAT) will also be accepted, with RDI 5-60, with greater than 75% of the apneas and hypopneas being obstructive in nature.
• Should be getting at least 6 hours of sleep nightly.
• BMI between 18.5 and 35
• Symptomatic, with polysomnography (PSG) showing AASM AHI 5-60 and symptoms attributable to OSA, with greater than 75% of the apneas and hypopneas being obstructive in nature. Home sleep apnea testing (HSAT) will also be accepted, with RDI 5-60, with greater than 75% of the apneas and hypopneas being obstructive in nature.
• Attempted nightly use for at least 2 weeks (at least 12/14 nights), with average use \< 4 hours, and difficulty tolerating PAP during a titration study, with complaints of difficulty breathing with CPAP or other difficulties that are not clearly related to identifiable causes (claustrophobia, mask discomfort, untreated RLS, untreated mouth leak, poor sleep hygiene, drug use, etc.).

You may not qualify if:

• Presence of symptomatic swallowing disorders, neuromuscular disorders affecting the upper airway, or neurodegenerative disorders.
• Co-existing sleep disorders such as narcolepsy, untreated restless legs syndrome, circadian rhythm disorders, or behavioral insomnia/poor sleep hygiene.
• Clinically significant congenital or acquired anomalies or history of surgery on the head and neck, excluding adenotonsillectomy, turbinate reduction, and septoplasty. Participants who had a tongue tie release outside of the newborn period will be excluded, but those who had tongue tie release in the newborn period will be eligible.
• Known complex sleep apnea or a history of conditions that are associated with the development of complex sleep apnea, such as heart failure, atrial fibrillation, a history of stroke, or opioid use.
• Prescription or nonprescription stimulant use (excluding caffeine).
• Substance use disorder or nightly alcohol consumption, as these significantly interfere with normal sleep.
• Current unstable illness (such as asthma, hypertension, cancer, etc.), kidney failure with restrictions on fluid consumption, or unplanned hospitalization in the past year for an ongoing condition.
• Risk factors for harm from expiratory strength testing and training: history of spontaneous pneumothorax, presence of CSF drain, recent trauma involving head, neck, or chest, history of recurrent epistaxis, history of esophageal surgery, active or recent hemoptysis, history of lung transplant or lung resection, eardrum rupture or any other condition of the ear, uncontrolled gastroesophageal reflux, abdominal hernia or recent hernia repair, urinary or fecal incontinence, presence of aneurysm (such as cerebral or aortic).
• Participants with CPAP intolerance only: Latex allergy in themselves or household members (due to balloon use in exercises).
• Allergy to Micropore paper tape (used in home sleep testing and for participants with CPAP intolerance during 2-week CPAP trial and exercise intervention).
• Pregnancy, actively trying to get pregnant, or sexually active and not using birth control (for people of child-bearing potential).
• Has a condition that increases the risk of developing cancer, such as BRCA1/2.
• Does not speak English fluently.

Sponsors & Collaborators

• Denise Dewald: lead
• American Academy of Sleep Medicine: collaborator
• Case Western Reserve University: collaborator
• MetroHealth Medical Center: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• Denise Dewald, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty, Pulmonary, Critical Care and Sleep Medicine- Department of Medicine

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 22, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: March 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning year 1 after first publication with no end date.
• Access Criteria: No data use agreement or data request will be required.

Locations

US (1)