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Clinical Trials/NCT03264963
NCT03264963
Completed
Not Applicable

Upper Airway Training for Treatment of Snoring Using Smartphone Application

University of Minnesota0 sites32 target enrollmentDecember 15, 2016
ConditionsSnoring

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Snoring
Sponsor
University of Minnesota
Enrollment
32
Primary Endpoint
Snoring Intensity
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2016
End Date
May 18, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Fluent in English.
  • Age is between 20 and
  • 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.
  • 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.

Outcomes

Primary Outcomes

Snoring Intensity

Time Frame: 12 weeks

Snoring sounds \>60 db

Snoring Rate

Time Frame: 12 weeks

Snoring sounds/hour of sleep

Secondary Outcomes

  • Sleepiness(12 weeks)
  • Sleep Quality(12 weeks)
  • Bed Partner Sleep Quality(12 weeks)

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