Upper Airway Training for Treatment of Snoring | NCT03264963

Studies
Upper Airway Training for Treatment of Snoring

NCT03264963

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Nov 8, 2017Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Snoring

Interventions

Smart phone game play
Control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2016Actual

Primary Completion Date

Apr 15, 2017Actual

Completion Date

May 18, 2017Actual

First Submitted Date

Aug 23, 2017

First Submission Date that Met QC Criteria

Aug 24, 2017

First Posted Date

Aug 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Name	Class
UMN Medical Devices Center	UNKNOWN
Fairview Sleep Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
Control	Active Comparator		Other: Control
Intervention	Experimental		Other: Smart phone game play

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Snoring Intensity	Snoring sounds >60 db	12 weeks
Snoring Rate	Snoring sounds/hour of sleep	12 weeks

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.
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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30032464	Derived	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.

ID	Term
D012135	Respiratory Sounds
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms