Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01772017




Registration number
NCT01772017
Ethics application status
Date submitted
30/10/2012
Date registered
21/01/2013
Date last updated
24/11/2015

Titles & IDs
Public title
A Trial to Evaluate a Device for the Treatment of OSA and Snoring
Scientific 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)
Secondary ID [1] 0 0
OPEN-002
Universal Trial Number (UTN)
Trial acronym
OPEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Snoring 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Tongue Advancement Retainer Device

Experimental: Device Treatment - Tongue Advancement Retainer Device


Treatment: Devices: Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
Timepoint [1] 0 0
Approximately 6 weeks
Secondary outcome [1] 0 0
Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.
Timepoint [1] 0 0
Approximately 6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sleepy, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01772017
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian Weeks, MD
Address 0 0
Senta Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01772017