MedDataX Logo

Upper Airway Training for Treatment of Snoring

NCT ID: NCT03264963

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2017-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Snoring

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Upper airway exercises Smart phone application

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Recording of sleep environment 2 nights per week for 12 weeks

Intervention

Group Type EXPERIMENTAL

Smart phone game play

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Control

Recording of sleep environment 2 nights per week for 12 weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UMN Medical Devices Center

UNKNOWN

Sponsor Role collaborator

Fairview Sleep Center

UNKNOWN

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30032464 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1606S88671

Identifier Type: -

Identifier Source: org_study_id