Upper Airway Training for Treatment of Snoring

Snoring Clinical Trial

Official title:

Upper Airway Training for Treatment of Snoring Using Smartphone Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264963
• Other study ID #: 1606S88671
• Status: Completed
• Phase: N/A
• First received: August 23, 2017
• Last updated: November 6, 2017
• Start date: December 15, 2016
• Est. completion date: May 18, 2017

Study information

• Verified date: November 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 18, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Snoring

Intervention

Other:
• Smart phone game play
Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks
• Control
Recording of sleep environment 2 nights per week for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Fairview Sleep Center, UMN Medical Devices Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Snoring Intensity	Snoring sounds >60 db	12 weeks
Primary	Snoring Rate	Snoring sounds/hour of sleep	12 weeks
Secondary	Sleep Quality	Self reported sleep quality on likert scale (0 to 5)	12 weeks
Secondary	Bed Partner Sleep Quality	Bed partner reported sleep quality on likert scale (0 to 5)	12 weeks
Secondary	Sleepiness	Epworth sleepiness score	12 weeks