NCT06786117
Swallowing in OSA & CPAP Intolerance
Enrolling by Invitation
NAAges 40–70InterventionalTreatmentDenise DewaldInvestigator-initiated
~50 participants
Updated 2025-03-11 on ClinicalTrials.gov
What's tested:SLP swallowing exercisesmyofunctional exercises
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over at the time of MBS (within 2-4 weeks of study enrollment)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Denise Dewald, MD · PRINCIPAL_INVESTIGATOR · MetroHealth Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.).
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
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.
What this trial measures
- Prevalence of premature spillage in participants with OSA who are CPAP intolerant vs participants who are successful nasal CPAP users or who have healthy airwaysat the time of MBS (within 2-4 weeks of study enrollment)
MBS images will be evaluated for premature spillage during oral bolus formation. Comparison of prevalence of premature spillage will be made between study groups.
- Effect of swallowing exercise intervention for CPAP intolerance3-7 months after enrollment
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.