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New treatment option for Obstructive Sleep Apnea
Official title Myofunctional Therapy for Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT07301125
What this study is testing
- What it's testing
- The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults aged 18-65
- New diagnosis of OSA (AHI ≥ 5) or failure of first-line OSA treatment
- Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months
You likely can't join if
- Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)
- Severe nasal obstruction
- Severe ankyloglossia
- Craniofacial abnormality
- Severe pulmonary disease
- Severe post-traumatic stress disorder (PCL-5 \> 33)
See the full eligibility criteria
- Adults aged 18-65
- New diagnosis of OSA (AHI ≥ 5) or failure of first-line OSA treatment
- Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months
- Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)
- Severe nasal obstruction
- Severe ankyloglossia
- Craniofacial abnormality
- Severe pulmonary disease
- Severe post-traumatic stress disorder (PCL-5 \> 33)
- Very severe insomnia (ISI \> 22)
- Body mass index (BMI) ≥30 kg/m2.
- History of TBI
- Known oropharyngeal or esophageal dysphagia
- Pregnancy
- Allergy to topical anesthetic
- Inability to fast for 6 hours
- Recent facial trauma
- Recent nasal, pharyngeal, laryngeal, or esophageal surgery
- Known nasal, pharyngeal or esophageal obstruction
- Current upper respiratory infection
- Insufficient internet/computer access to participate in remote study visit
- Severe excessive daytime sleepiness (risk of motor vehicle accidents)
- Heart failure, recent stroke, heart attack, etc.
- Nasal Obstruction Symptom Evaluation (NOSE) Scale \>15
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.