NCT07301710 · Uniformed Services University of the Health Sciences
Low-Tech Treatments for Obstructive Sleep Apnea
What this study is about
The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI.
View original scientific description
The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI. The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and whether people have different outcomes depending on their history of TBI.
Interventions
BEHAVIORAL
High-Resistance Breathing and Drinking Exercises
Three months of drinking at least 32-oz of water daily through a high-resistance nozzle, and inhaling and exhaling 60 times per day through a high-resistance breathing device
BEHAVIORAL
Low-Resistance Breathing and Drinking Exercises
Three months of drinking 32-oz of water daily through a low-resistance nozzle, and inhaling and exhaling 40 times per day through a low-resistance breathing device
Primary outcome measures
Apnea-Hypopnea Index (AHI)
Time frame: From enrollment to end of three-month intervention
AHI is the number of apneic and hypopneic episodes per hour of sleep. The scores start at zero, meaning no events are taking place. A mild score falls in the range of 5-15; moderate 15-30, and a severe diagnosis is 30 or more events per hour. Pre-intervention AHI is obtained from standard-of-care in-clinic sleep study. Post-intervention AHI is obtained from an in-clinic sleep study conducted as part of this research.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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;
- Ability to follow directions and perform the required exercises;
- Age between 18-65 yr.
Exclusion criteria
- Current use of OSA treatment;
- Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia);
- Severe nasal obstruction; 4) severe ankyloglossia; 4) craniofacial abnormality; 5) severe pulmonary disease; 6) severe post-traumatic stress disorder; 7) very severe insomnia; 8) body mass index (BMI) ≥30 kg/m2
Where
- Bethesda, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations