A Trial to Evaluate a Device for the Treatment of OSA and Snoring (OPEN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sleepy, Inc
ClinicalTrials.gov Identifier:
NCT01772017
First received: October 30, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea
Snoring
Device: Tongue Advancement Retainer Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi Center, Open Label Study to Evaluate a Tongue Advancement Retainer Device in the Treatment of Subjects With Obstructive Sleep Apnea and Snoring (OPEN Trial)

Resource links provided by NLM:


Further study details as provided by Sleepy, Inc:

Primary Outcome Measures:
  • Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events. [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: Yes ]
    Safety endpoint will be measured throughout the duration of the study.


Secondary Outcome Measures:
  • Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase. [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: No ]
    Efficacy Endpoint will be measured at baseline and at end of treatment.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Treatment
Tongue Advancement Retainer Device
Device: Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
Other Name: Sleepy Tongue Advancement Retainer Device

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772017

Locations
United States, California
Senta Clinic
San Diego, California, United States, 92120
Visalia Medical Clinic
Visalia, California, United States, 93291
Australia, New South Wales
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Sponsors and Collaborators
Sleepy, Inc
Investigators
Principal Investigator: Brian Weeks, MD Senta Clinic
  More Information

No publications provided

Responsible Party: Sleepy, Inc
ClinicalTrials.gov Identifier: NCT01772017     History of Changes
Other Study ID Numbers: OPEN-002
Study First Received: October 30, 2012
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sleepy, Inc:
Obstructive Sleep Apnea
OSA
Snoring
Tongue Advancement Retainer Device

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Snoring
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds

ClinicalTrials.gov processed this record on July 28, 2014