A Trial to Evaluate a Device for the Treatment of OSA and... | NCT01772017

Studies
A Trial to Evaluate a Device for the Treatment of OSA and Snoring

NCT01772017

Sponsor

Sleepy, Inc

Status

Terminated

Last Update Posted

Nov 24, 2015Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea
Snoring

Interventions

Tongue Advancement Retainer Device

Countries

United States
Australia

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 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decided to discontinue study for business reasons.

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Oct 30, 2012

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 21, 2013Estimated

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 22, 2015

Last Update Posted Date

Nov 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.

Detailed Description

The Tongue Advancement Retainer Device is a device that was developed to treat subjects with OSA and snoring. The purpose of this study is to evaluate initial safety and effectiveness of this device in treating one or both conditions.

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

15Actual

Label	Type	Description	Intervention Names
Device Treatment	Experimental	Tongue Advancement Retainer Device	Device: Tongue Advancement Retainer Device

Name	Type	Description	Arm Group Labels	Other Names
Tongue Advancement Retainer Device	Device	Tongue Advancement Retainer Device	Device Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.	Safety endpoint will be measured throughout the duration of the study.	Approximately 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.	Efficacy Endpoint will be measured at baseline and at end of treatment.	Approximately 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Aged 18-65
- AHI greater than or equal to 10 but less than or equal to 60 (<10 AHI <60/hr)
- Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth

Additionally subjects will in the screening phase must:

Tolerate the device when being fitted
Used the device for >4 hours on at least two consecutive nights during the screening period.
Be able to reliably demonstrate proper installation of the device after fitting.
Be willing to trial the device for a 4 week period

Exclusion Criteria:

• Central sleep apnea events >10% of the total events
- Evidence of Cheyne stokes breathing
- Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior.
- Currently on regular treatment with prescription hypnosedatives or prescription stimulants
- Very severe OSA, defined as AHI>60/hour and/or minimum oxygen saturation <75%
- Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk)
- Previous surgery to treat OSA (other than nasal surgery)
- Evidence of periodontal disease or tooth mobility
- Severe nasal obstruction or enlarged tonsils based on clinical assessment
- Unstable cardiovascular disease (untreated hypertension acceptable).
- Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator
- Pregnant/Breast Feeding
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Senta Clinic		San Diego	California	92120	United States
Visalia Medical Clinic

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D020181	Sleep Apnea, Obstructive
D012913	Snoring