Low-Tech Treatments for Obstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniformed Services University of the Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- High-Resistance Breathing and Drinking Exercises
- Low-Resistance Breathing and Drinking Exercises
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov