NCT01772017

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

October 30, 2012

Last Update Submit

November 22, 2015

Conditions

Obstructive Sleep ApneaSnoring

Keywords

Obstructive Sleep ApneaOSASnoringTongue Advancement Retainer Device

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.

    Approximately 6 weeks

Study Arms (1)

Device Treatment

EXPERIMENTAL

Tongue Advancement Retainer Device

Device: Tongue Advancement Retainer Device

Interventions

Tongue Advancement Retainer DeviceDEVICE

Tongue Advancement Retainer Device

Also known as: Sleepy Tongue Advancement Retainer Device
Device Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Senta Clinic

San Diego, California, 92120, United States

Location

Visalia Medical Clinic

Visalia, California, 93291, United States

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSnoring

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Weeks, MD

    Senta Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2012

First Posted

January 21, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

AU(1)US(2)