Upper Airway Training for Treatment of Snoring

Upper Airway Training for Treatment of Snoring Using Smartphone Application

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.

Study Overview

• Status: Completed
• Conditions: Snoring
• Intervention / Treatment: Other: Control; Other: Smart phone game play

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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
Active Comparator: Control	Other: Control; Recording of sleep environment 2 nights per week for 12 weeks

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: UMN Medical Devices Center; Fairview Sleep Center

Publications and helpful links

General Publications

• Goswami U, Black A, Krohn B, Meyers W, Iber C. Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial. Sleep Breath. 2019 Mar;23(1):243-250. doi: 10.1007/s11325-018-1690-y. Epub 2018 Jul 21.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): April 15, 2017
• Study Completion (Actual): May 18, 2017

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Smart phone application; Upper airway exercises
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: 1606S88671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No