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Completed

NCT Number: NCT03264963

Upper Airway Training for Treatment of Snoring

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.

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Key information

Conditions

Snoring Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smart phone game play

Other

Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks

Control

Other

Recording of sleep environment 2 nights per week for 12 weeks

Primary outcomes

  1. Snoring Intensity

    Time frame: 12 weeks

    Snoring sounds >60 db

  2. Snoring Rate

    Time frame: 12 weeks

    Snoring sounds/hour of sleep

Secondary outcomes

  1. Sleep Quality

    Time frame: 12 weeks

    Self reported sleep quality on likert scale (0 to 5)

  2. Bed Partner Sleep Quality

    Time frame: 12 weeks

    Bed partner reported sleep quality on likert scale (0 to 5)

  3. Sleepiness

    Time frame: 12 weeks

    Epworth sleepiness score

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Fairview Sleep Center
  • UMN Medical Devices Center

Registry information

Official study title

Upper Airway Training for Treatment of Snoring Using Smartphone Application

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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