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

Obstructive Sleep Apnea Clinical Trial

— OPEN  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01772017
• Other study ID #: OPEN-002
• Status: Terminated
• Phase: N/A
• First received: October 30, 2012
• Last updated: November 22, 2015
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2015
• Source: Sleepy, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Intervention

Device:
• Tongue Advancement Retainer Device
Tongue Advancement Retainer Device

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
United States	Senta Clinic	San Diego	California
United States	Visalia Medical Clinic	Visalia	California

Sponsors (1)

Lead Sponsor	Collaborator
Sleepy, Inc

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No