Upper Airway Training for Treatment of Snoring

NCT03264963 | Completed

• 1 other identifier: 1606S88671
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Snoring

Keywords

Upper airway exercises; Smart phone application

Outcome Measures

Primary Outcomes (2)

• Snoring Intensity

  Snoring sounds \>60 db

  12 weeks

• Snoring Rate

  Snoring sounds/hour of sleep

  12 weeks

Secondary Outcomes (3)

• Sleep Quality

  12 weeks

• Bed Partner Sleep Quality

  12 weeks

• Sleepiness

  12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Other: Control

Intervention

EXPERIMENTAL

Other: Smart phone game play

Interventions

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

Intervention

Control OTHER

Recording of sleep environment 2 nights per week for 12 weeks

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• UMN Medical Devices Center: collaborator
• Fairview Sleep Center: collaborator

Related Publications (1)

• 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.

  PMID: 30032464 DERIVED

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 29, 2017
• Study Start: December 15, 2016
• Primary Completion: April 15, 2017
• Study Completion: May 18, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11