Clinical trial NCT01772017: A Trial to Evaluate a Device for the Treatment of OSA and Snoring
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Snoring
Keywords: Obstructive Sleep Apnea
OSA
Snoring
Tongue Advancement Retainer Device
Lead sponsor: Sleepy, Inc
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
timeFrame: Approximately 6 weeks
Secondary outcomes:
measure: Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.
timeFrame: Approximately 6 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Senta Clinic
state: California
city: Visalia
country: United States
facility: Visalia Medical Clinic
state: California
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Senta Clinic
name: Brian Weeks, MD
role: PRINCIPAL_INVESTIGATOR
References: