Upper Airway Training for Treatment of Snoring

Not Applicable

Completed

• Conditions: Snoring
• Interventions: Other: Control; Other: Smart phone game play

• Registration Number: NCT03264963
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Primary Completion: 2017-04-15
• Study Completion: 2017-05-18
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-29
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Fluent in English.

2. Age is between 20 and 65.

3. BMI less than 32

4. Less than 5% variance in weight since sleep study.

5. Snoring without health risk related to sleep apnea and not currently receiving treatment.

   1. Mild OSA or negative HSAT or PSG within past year with AHI 0-14
   2. Has refused oral appliances, CPAP, weight loss, surgery or positional therapy.

6. Owns an iPhone 4 or newer and is comfortable downloading and using apps.

7. Complaint of habitual snoring 3 or more nights per week

8. Rated by polysomnograph technologist as moderate or loud snoring.

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Exclusion Criteria

1. Non-fluent in English.
2. Persistent rhinitis diagnosis or nasal obstruction.
3. BMI > 32
4. Greater than 5% variance in weight since sleep study.
5. Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, RLS)
6. Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report.
7. Spouse/partner is also a habitual snorer.
8. Lacking ability to consent for themselves.
9. Heavy drinker (self reported average more than 2 drinks per day).
10. Regular narcotics (greater than 3 times/week)
11. Epworth sleepiness scale score > 11 or one near miss accident in the past 6 months.
12. Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	-
Intervention	Smart phone game play	-

Primary Outcome Measures

Name	Time	Method
Snoring Intensity	12 weeks	Snoring sounds \>60 db
Snoring Rate	12 weeks	Snoring sounds/hour of sleep

Secondary Outcome Measures

Name	Time	Method
Bed Partner Sleep Quality	12 weeks	Bed partner reported sleep quality on likert scale (0 to 5)
Sleepiness	12 weeks	Epworth sleepiness score
Sleep Quality	12 weeks	Self reported sleep quality on likert scale (0 to 5)