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

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea; Snoring
• Interventions: Device: Tongue Advancement Retainer Device

• Registration Number: NCT01772017
• Lead Sponsor: Sleepy, Inc

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-21
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-22
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Treatment	Tongue Advancement Retainer Device	Tongue Advancement Retainer Device

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Senta Clinic; 🇺🇸 San Diego, California, United States

Visalia Medical Clinic; 🇺🇸 Visalia, California, United States