Obstructive Sleep Apnea (OSA), Sleep Quality, Snoring
Conditions
Keywords
OSA, Myotherapy, Myofunctional Exercises, Snoring, Sleep Apnea, Sleep Quality
Brief summary
This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.
Detailed description
Outcomes will be measured using tone analysis, snoring recording apps, and oximeters.
Interventions
OTHERExercise
Mouth, tongue, and throat exercise to strengthen the airway, reducing its collapsibility.
Sponsors
Case Western Reserve University
American Association of Orthodontists Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Both groups receive the same exercise prescription, but one is through a phone application and the other is a piece of paper.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with mild, moderate, and severe OSA who rejected/failed CPAP or other therapeutic options will be invited to participate in the study.
Exclusion criteria
1. Age lower than 18 or higher than 75. 2. BMI \> 40 3. Alcoholism or drug abuse 4. A-fib, pacemaker, CHF, strokes, narcotics 5. Neuromuscular disease 6. Use of benzodiazepine hypnotics (may affect muscle tone) 7. Restricted tongue movement 8. Permanently blocked nose 9. TMJ disorder. 10. Lost to follow-up 11. Gained or lost ≥5% of body weight during 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Belun Ring Oxygen Saturation | baseline and then monthly for 3 months. | Oximeter with pulse rate registration. The oximeter will provide the average level of oxygen saturation in the blood, provided in a percentage outcome. . |
| Belun Ring lowest Oxygen Saturation Level | baseline and then monthly for 3 months. | Oximeter with pulse rate registration. The oximeter will provide the lowest level of oxygen saturation recorded as a percentage. |
| Belun Ring Oxygen Saturation under 70% | baseline and then monthly for 3 months. | Oximeter with pulse rate registration. The oximeter will provide the percentage of sleep that was under 70% SpO2. |
| Belun Ring AHI | baseline and then monthly for 3 months. | Oximeter with pulse rate registration. The oximeter provides the Apnea/Hypopnea Index which is the number of apneic events per hour of sleep. |
| Belun Ring Pulse Rate | baseline and then monthly for 3 months. | Oximeter with pulse rate registration. The oximeter provides the pulse rate as the average beats per minute with standard deviation, and range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SnoreLab app | baseline and monthly for 3 months. | A mobile phone app that records snoring when present, and categorizes into amount and level. Possible outcomes are: none, mild, moderate, severe, and epic. |
| Tongue Elevation strength | baseline and monthly for 3 months. | The Iowa Oral Performance Instrument, is a validated intraoral device that measures tongue elevation strength in kPa. |
| Tongue Protrusion strength | baseline and monthly for 3 months. | The Iowa Oral Performance Instrument is a validated intraoral device that measures tongue protrusion strength in kPa. |
| Buccinator strength | baseline and monthly for 3 months. | The Iowa Oral Performance Instrument is a validated intraoral device that measure the buccinator muscle strength in kPa. |
| STOP-Bang Questionnaire | baseline and monthly for 3 months. | STOP-Bang is a validated tool that determines if the subject is at no, low, moderate, or severe risk of sleep-apnea. It provides an objective score that ranges from 0 to 8. |
| Nasal Obstruction Assessment (NOSE) Questionnaire Score | baseline and monthly for 3 months. | NOSE is a validated tool that determines the level of difficulty that the subject experienced in breathing through their nose in the past 3 months. The questionnaire provides an objective score stating the risk level that ranges from 0 to 100 with lower scores indicating less nasal blockage and higher scores indicating worse nasal blockage. |
| PROMIS Sleep Disturbance 8b Short Form Questionnaire | baseline and monthly for 3 months. | Assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each question usually has five response options ranging in value from one to five. Values are summed to generate a raw score that is then translated to a t-score with a mean of 50, std of 10. |
| Epworth Daytime Sleepiness Questionnaire | baseline and monthly for 3 months. | This is a validated tool that measures a person's daytime sleepiness and is commonly used to help diagnose sleep disorders. Eight prompts with each response scored from 0-3. Higher scores indicates greater sleepiness. It provides an objective score that can range from 0 to 24. |
| PROMIS Sleep Impairment 8a Short Form Questionnaire | baseline and monthly for 3 months. | Assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question usually has five response options ranging in value from one to five. Values are summed to generate a raw score which is then translated to a t-score with a mean of 50, std of 10. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJuan M Palomo, DDS, MSD
Case Western Reserve University
Outcome results
None listed