Upper Airway Training for Treatment of Snoring

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to reduce the incidence or intensity of snoring in a patient population of known simple snorers without sleep apnea using smartphone based application which allows participants to play voice controlled games using various articulations resulting in tongue base movements.

Official Title
-----------------
Upper Airway Training for Treatment of Snoring Using Smartphone Application

Conditions
-----------------
Snoring

Intervention / Treatment
-----------------
* Other: Smart phone game play
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluent in English. Age is between 20 and 65. BMI less than 32 Less than 5% variance in weight since sleep study. Snoring without health risk related to sleep apnea and not currently receiving treatment. Mild OSA or negative HSAT or PSG within past year with AHI 0-14 Has refused oral appliances, CPAP, weight loss, surgery or positional therapy. Owns an iPhone 4 or newer and is comfortable downloading and using apps. Complaint of habitual snoring 3 or more nights per week Rated by polysomnograph technologist as moderate or loud snoring. Exclusion Criteria: Non-fluent in English. Persistent rhinitis diagnosis or nasal obstruction. BMI > 32 Greater than 5% variance in weight since sleep study. Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, RLS) Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report. Spouse/partner is also a habitual snorer. Lacking ability to consent for themselves. Heavy drinker (self reported average more than 2 drinks per day). Regular narcotics (greater than 3 times/week) Epworth sleepiness scale score > 11 or one near miss accident in the past 6 months. Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Other: Control<br>* Recording of sleep environment 2 nights per week for 12 weeks<br>|
| Experimental: Intervention<br> | Other: Smart phone game play<br>* Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Snoring Intensity | Snoring sounds >60 db | 12 weeks | 
| Snoring Rate | Snoring sounds/hour of sleep | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Self reported sleep quality on likert scale (0 to 5) | 12 weeks | 
| Bed Partner Sleep Quality | Bed partner reported sleep quality on likert scale (0 to 5) | 12 weeks | 
| Sleepiness | Epworth sleepiness score | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper airway exercises, Smart phone application