Clinical trial NCT06786117: Swallowing in OSA & CPAP Intolerance
Official title: Swallowing in Obstructive Sleep Apnea (OSA) & Continuous Positive Airway Pressure (CPAP) Intolerance
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
name: Case Western Reserve University
name: MetroHealth Medical Center
First posted: 2025-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Detailed description: Obstructive sleep apnea (OSA) is a common disorder in which the throat narrows abnormally or even collapses fully during sleep. The narrowing leads to sleep disruption and increases the risk of many chronic health conditions. We do not understand why the throat narrows in some people during sleep but not in others. While being overweight or obese increases a person's risk of OSA, it is only one part of the problem. Some thin adults and children have OSA, and many overweight or obese people do not have OSA. In addition, many people with OSA struggle to benefit from current OSA treatments like continuous positive airway pressure (CPAP), which uses air pressure to hold the airway open during sleep. We need improved understanding of OSA in order to improve treatment of it.

The throat is used for swallowing as well as for breathing. Hence it should not be surprising if a throat that has trouble staying open during sleep might also have some abnormalities during swallowing. Indeed, some research has shown subtle abnormalities in swallowing in people who have snoring or OSA compared to people who don't snore at all. We would like to further develop this line of research.

This study has two arms: an observational arm to look for differences in swallowing, and an interventional arm to see if swallowing exercises can improve people's ability to use CPAP.

The purpose of the observational arm is to look for differences in swallowing between healthy people and people who have obstructive sleep apnea (OSA) using a variety of measurement techniques, some of which have not been done in the past. Understanding the differences in swallowing may help us to develop new treatments for OSA. It may also help us to figure out how to prevent OSA from developing in the first place. We are also looking to see if there are swallowing differences between people with OSA who don't tolerate CPAP compared to people who do well with CPAP. If there are differences, these differences may help us better understand why some people do not tolerate CPAP, and may lead to the development of novel treatments such as exercise therapies to help them do better with CPAP.

The interventional arm will test exercise therapies to see if they will help people who struggle with CPAP. The goal is not to cure OSA, but to help people be able to use CPAP better so that they can sleep better. Participants who have abnormalities in their swallowing study will get exercises from speech language pathologists (SLP, also known as speech therapists) aimed at trying to correct those abnormalities. Participants will then try to use CPAP again. Participants who still can't sleep well with CPAP after those exercises, or who don't have abnormalities on the swallowing study, will get another type of exercise therapy based on an exercise technique called orofacial myofunctional therapy (OMT). This therapy aims to train exclusive nasal breathing and correct variations in the swallow. This sort of exercise technique has had some success in improving CPAP use as well as in reducing the severity of OSA. We have created a streamlined exercise protocol based on these techniques that we hope will provide better results in a shorter period of time. At the end of the exercise interventions, the participants will repeat the investigations that were done at the beginning of the study.

Investigations will include home sleep testing, CPAP trials (only for participants with OSA and CPAP intolerance), a modified barium swallow study (MBS), a measurement visit, and questionnaires. During the measurement visit, there will be assessments of the strength of the tongue, lips, and cheeks, assessment of nasal airflow, respiratory muscle strength, restrictions in tongue mobility (tongue tie), posture, dental and facial form, and eating and drinking. The modified barium swallow study uses x-rays; the amount of radiation from the procedure is about what a person would receive from about 4.5 months of background radiation. It is a little bit more radiation than what a person would receive from a mammogram, but much less than what a person would receive from a CT scan.

Eligibility criteria: Inclusion Criteria for healthy airways participants:

* 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

Inclusion Criteria for participants with OSA who are successful CPAP users:

* 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

Inclusion Criteria for participants with OSA who have CPAP intolerance:

* 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.).
* Must be able to breathe through their noses comfortably while awake.
* Able and willing to do daily swallowing exercises (15-30 minutes per day) for a total of 14 weeks.
* Able and willing to use a positional therapy device to avoid supine sleep and to adjust their CPAP device settings (instructions will be provided).
* BMI between 18.5 and 35
* Not actively undergoing bariatric treatment or planning to start bariatric treatment within the next 6 months.

Exclusion Criteria for all participants:

* 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.

Primary outcomes:
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
timeFrame: at the time of MBS (within 2-4 weeks of study enrollment)
measure: Effect of swallowing exercise intervention for CPAP intolerance
timeFrame: 3-7 months after enrollment
Secondary outcomes:
measure: Baseline length of the oropharyngeal seal during bolus formation in the modified barium swallow study (MBS)
timeFrame: at the time of MBS (within 2-4 weeks of study enrollment)
measure: Baseline breathing route during wakefulness as assessed by MBS
timeFrame: at the time of MBS (within 2-4 weeks of study enrollment)
measure: Baseline tongue position as observed during nasal breathing during MBS
timeFrame: at the time of MBS (within 2-4 weeks of study enrollment)
measure: Baseline soft palate shape as observed during nasal breathing during MBS
timeFrame: at the time of MBS (within 2-4 weeks of study enrollment)
measure: Baseline assessment of Tipper- vs Dipper-type oral swallowing
timeFrame: at the time of MBS (within 2-4 weeks of study enrollment)
measure: Baseline assessment of anterior tongue strength
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment); participants with CPAP intolerance will have a second measurement visit at the end of the study
measure: Baseline assessment of posterior tongue strength
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline assessment of combined lip/cheek strength
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline assessment of combined lip/cheek activation during swallowing
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline maximum expiratory pressure
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline maximum inspiratory pressure via oral route
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline sniff inspiratory pressure (SNIP) via nasal route
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline awake resting breathing route assessment by nasal pressure signal
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline assessment of Mallampati score
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline assessment of Friedman tongue position score
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline anterior tongue tie evaluation
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline posterior tongue tie evaluation
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline visual differences in swallowing
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline head tilt angle differences
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline postural assessment
timeFrame: at the time of the measurement visit (within 2-4 weeks of study enrollment)
measure: Baseline CPAP waveform differences between participants with CPAP intolerance and participants who are successful CPAP users (participants with OSA only)
timeFrame: At study enrollment (successful CPAP users) or after baseline 2-week CPAP trial (participants with CPAP intolerance), within 1 months of enrollment
measure: Baseline differences in nasal pressure signal during sleep between participants with CPAP intolerance and participants who are successful CPAP users (participants with OSA only)
timeFrame: At enrollment (if recent PSG is already available) or after completion of home sleep testing, within one month of enrollment
measure: Baseline Swallowing Disturbance Questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline Epworth Sleepiness Scale (ESS)
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline Insomnia Severity Index (ISI) questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline Short Calgary Sleep Apnea Quality Of Life Index questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline Short Form Health Survey-36 questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline PROMIS Sleep Disturbance short form 8b questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline PROMIS Sleep-related impairment short form 8a questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Baseline sleep habits and swallowing and CPAP observations questionnaire
timeFrame: When baseline questionnaires are returned, within one month of enrollment.
measure: Post-intervention assessment of AHI by home sleep testing (participants with CPAP intolerance only)
timeFrame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention changes in nasal airflow during sleep (participants with CPAP intolerance only)
timeFrame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of pulse oxygen nadir by home sleep testing (participants with CPAP intolerance only)
timeFrame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of time with oxygen saturation less than 90% during home sleep testing (participants with CPAP intolerance only)
timeFrame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention differences in nasal pressure signal during home sleep testing (participants with CPAP intolerance only)
timeFrame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment
measure: Post-intervention assessment of oral bolus formation during MBS (participants with CPAP intolerance only)
timeFrame: Within 2-4 weeks of the completion of the final swallowing exercise intervention, which will be 3-7 months after enrollment
measure: Post-intervention length of oropharyngeal seal during bolus formation in modified barium swallow study (MBS) (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention breathing route during wakefulness by MBS (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention tongue position as observed during nasal breathing during MBS (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention soft palate shape as observed during nasal breathing during MBS (participants with CPAP intolerance only)
timeFrame: at time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of Tipper- vs Dipper-type swallowing (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of anterior tongue strength (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of posterior tongue strength (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of combined lip/cheek strength (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of combined lip/cheek activation during swallowing (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention maximum expiratory pressure (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention maximum inspiratory pressure via oral route (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention sniff inspiratory pressure (SNIP) via nasal route (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention awake resting breathing route assessment by nasal pressure signal (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of Mallampati score (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention assessment of Friedman tongue position score (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention anterior tongue tie evaluation (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention posterior tongue tie evaluation (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention visual differences in swallowing (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention head tilt angle differences (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention postural assessment (participants with CPAP intolerance only)
timeFrame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention CPAP waveform differences (participants with CPAP intolerance only)
timeFrame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment.
measure: Post-intervention CPAP residual AHI (participants with CPAP intolerance only)
timeFrame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment.
measure: Post-intervention number of nightly CPAP mask removals (participants with CPAP intolerance only)
timeFrame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment.
measure: Post-intervention Swallowing Disturbance Questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention Epworth Sleepiness Scale (ESS) (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention Pittsburgh Sleep Quality Index (PSQI) questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention Insomnia Severity Index (ISI) questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention Short Calgary Sleep Apnea Quality Of Life Index questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention Short Form Health Survey-36 questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention PROMIS Sleep Disturbance short form 8b questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention PROMIS Sleep-related impairment short form 8a questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
measure: Post-intervention sleep habits and swallowing and CPAP observations questionnaire (participants with CPAP intolerance only)
timeFrame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done
Other outcomes:
measure: Long term outcome of swallowing exercise intervention on average nightly hours of CPAP use (participants with CPAP intolerance only)
timeFrame: 3-15 months after completion of the final exercise intervention (depending on whether participant will need a CPAP device)
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Denise Dewald, MD
role: PRINCIPAL_INVESTIGATOR
References: