Low-Tech Treatments for Obstructive Sleep Apnea

ConditionsObstructive Sleep Apnea (OSA)Traumatic Brain Injury (TBI)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

High-Resistance Breathing and Drinking Exercises
Behavioral
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
Low-Resistance Breathing and Drinking Exercises
Behavioral
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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Myofunctional TherapyExperimental treatment 1 intervention

Group B: Relaxation TherapySham comparator 1 intervention

Trial outcomes

Primary outcomes

Apnea-Hypopnea Index (AHI)

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.

Time frame

From enrollment to end of three-month intervention

Secondary outcomes

SpO2

Oxygen saturation measured during the in-clinic sleep studies. Normal levels range between 95-100%.

Time frame

From enrollment to end of three-month intervention

Snore Index

Number of snoring episodes per hour of sleep

Time frame

From enrollment to end of three-month intervention

Epworth Sleepiness Scale (ESS)

A self-assessment of daytime sleepiness comprising eight questions on a four-point scale (0-3; total range = 0-24). Higher scores indicate greater daytime sleepiness.

Time frame