Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000009718
Ethics application status
Approved
Date submitted
3/01/2013
Date registered
4/01/2013
Date last updated
4/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel device in the treatment of Obstructive Sleep Apnea 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.
Secondary ID [1] 281727 0
Nil
Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1138-2366
Trial acronym
OPEN 002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA) 288027 0
Snoring 288028 0
Condition category
Condition code
Respiratory 288402 288402 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tongue Advancement Retainer Device has been designed to decrease the severity of OSA and Snoring by maintaining the tongue in an extended position, thus preventing the tongue from falling backwards during sleep, preventing the engagement with the soft palate and airway.

Participants will wear the device nightly for a 4 week period. The device will be fitted by the participant before going to sleep and removed upon waking. The clinician will instruct the participant on how to correctly fit the device, and choose the most appropriate size for the participants mouth.

A polysomnogram (PSG), otherwise known as a sleep study, will be conducted at baseline and end of study to assess efficacy of the device. For the sleep study the participant attends the sleep lab in the early evening, and over the next 1–2 hours is introduced to the setting and "wired up" so that multiple channels of data can be recorded when he/she falls asleep. The recording will measure breathing, heart rate, brain activity, and body movement all night. During the study, the technician observes sleep activity by looking at the video monitor and the computer screen that displays all the data second by second. The test is completed and the participant goes home around 7 a.m.
Intervention code [1] 286265 0
Treatment: Devices
Comparator / control treatment
Uncontrolled.
The trial is an unblinded, non-randomised, single arm trial to assess safety and efficacy.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288575 0
The primary outcomes are the safety of the device measured through the safety data; and efficacy measured in the change in the overall Apnea Hypopnea Index (AHI).

The AHI is a standard clinical measurement to determine severity of OSA. It is the average number of apneas or hypopneas that are observed during the sleep study each hour.
Timepoint [1] 288575 0
Week 4 - End of Study
Primary outcome [2] 288579 0
The primary outcomes are the safety of the device measured through the safety data. All Adverse events (AE's) will be collected from the time of enrollment. AE's will be tabulated by their preferred terms and severity. Serious
Adverse and Device related events will also be tabulated. In addition all events will be listed in the listings. The tables and listings will presented be as the number and percentage for each AE.

Oral appliances for snoring and sleep apnea are generally well tolerated after an initial acclimatization phase. They may produce tooth and jaw discomfort, excessive salivation, and a temporary awareness of bite change on waking. The symptoms tend to be minor and transient, dissipating after 2 to 3 weeks of use. Devices which are in contact with the teeth may be associated with movement of teeth, although when this occurs it is usually minor. Temporo mandibular joint dysfunction is a rare complication of treatment. The oral appliance may dislodge during sleep, but the size of the device minimizes the risk of choking. It is theoretically possible that breakage of the device could result in aspiration a component of the device, but that has not been reported in the literature.

In summary the risks include: Jaw discomfort, Salivation, Bite change, Teeth movement, Temporo-mandibular dysfunction, Choking, Aspiration.

This device specifically engages the tongue although several steps have been taken in the design of the device to minimize the likelihood of any adverse effects on the tongue, abrasion, inflammation, swelling, soreness, bruising or incision of the tongue or surrounding soft or hard structures of the oral cavity is possible. In all likelihood, all of these events are likely to be transient.
Timepoint [2] 288579 0
From enrollment to End of Study (EOS).
Secondary outcome [1] 300491 0
Compliance:
Each morning the participant completes a short questionnaire, which includes the total hours the patient felt they slept that night, and the total hours slept with the device. This is a subjective measurement. The proportion of subjects in the treatment phase who note wearing the device >=4 hours each night for >=70% of the treatment period. The result will be presented as the number and percentage of device usage.
Timepoint [1] 300491 0
From enrollment to EOS
Secondary outcome [2] 300502 0
Tolerability:
Each morning the participant completes a short questionnaire, which includes the total hours the patient felt they slept that night, and the total hours slept with the device. This is a subjective measurement. The proportion of subjects who used the device by night/week/overall regardless of time the device was used. The result will be presented as the number and percentage of device usage.

Timepoint [2] 300502 0
From enrollment to EOS
Secondary outcome [3] 300504 0
Tolerability:
Subjective total hours of device usage/subjective total hours of sleep by night/week/overall. Each morning the participant completes a short questionnaire, which includes the total hours the patient felt they slept that night, and the total hours slept with the device. The result will be presented as the number and percentage of device usage.
Timepoint [3] 300504 0
From enrollment to EOS
Secondary outcome [4] 300505 0
Tolerability:
Subjective total hours of device usage/subjective total hours of sleep by night/week/overall. Each morning the participant completes a short questionnaire, which includes the total hours the patient felt they slept that night, and the total hours slept with the device. The proportion of subjects in the treatment phase who wear the device >4 hours by night/week/overall will be presented as the number and percentage of device usage.
Timepoint [4] 300505 0
From enrollment to EOS
Secondary outcome [5] 300506 0
Efficacy:
Changes in the Sleep Study results from baseline to EOS. All PSG's report set criteria as per the American Academy of Sleep Medicine Criteria. The mean results from the PSG will be summarised as n, mean, Standard Deviation, Range for baseline and EOS, and the mean change.
Timepoint [5] 300506 0
EOS

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)
Fluency in both written and spoken English
Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth
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 upper airway surgery for 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.
Inability to understand the English language

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trial is an unblinded, non-randomised, single arm trial.

Participants who agree to participate will undergo the informed consent process. After written informed consent is obtained, a unique subject number will be assigned to the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable: The trial is an unblinded, non-randomised, single arm trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The safety of the device will be measured through the safety data. All Adverse Events (AE's) will be presented in the the listings. Adverse events with a >= 5% incidence rate will be presented in the tables.

The efficacy endpoints are change from baseline. The primary endpoint mean change will be presented as the mean at baseline, mean at End Of study (EOS), and a mean change score with a 95% CI.

The secondary endpoints will be presented as the mean at baseline, end of study and mean change only.

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
7/01/2013
Actual
7/01/2013
Date of last participant enrolment
Anticipated
31/10/2013
Actual
8/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 358 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 6152 0
2065 - Royal North Shore Hospital
Recruitment outside Australia
Country [1] 4773 0
United States of America
State/province [1] 4773 0
California & Texas

Funding & Sponsors
Funding source category [1] 286516 0
Commercial sector/Industry
Name [1] 286516 0
Sleepy Inc.
Country [1] 286516 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Sleepy Inc.
Address
2570 W. El Camino Real, Suite 310
Mountain View, CA 95050
Country
United States of America
Secondary sponsor category [1] 285303 0
None
Name [1] 285303 0
Address [1] 285303 0
Country [1] 285303 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288589 0
North Sydney Local Health District
Ethics committee address [1] 288589 0
Ethics committee country [1] 288589 0
Australia
Date submitted for ethics approval [1] 288589 0
04/10/2012
Approval date [1] 288589 0
24/10/2012
Ethics approval number [1] 288589 0
HREC/12/HAWKE/335. NSLHD: 1212-438M

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36826 0
Prof Peter A. Cistulli
Address 36826 0
Royal North Shore Hospital
Reserve Rd, St. Leonards,
NSW 2065, Australia
Country 36826 0
Australia
Phone 36826 0
Australia
Fax 36826 0
+61-2-99268673
Email 36826 0
peter.cistulli@sydney.edu.au
Contact person for public queries
Name 36827 0
Peter Singh
Address 36827 0
Royal North Shore Hospital
Reserve Rd, St. Leonards,
NSW 2065, Australia
Country 36827 0
Australia
Phone 36827 0
+61 2 9463 2925
Fax 36827 0
+61 2 9463 2099
Email 36827 0
peter.singh@sydney.edu.au
Contact person for scientific queries
Name 36828 0
Peter Singh
Address 36828 0
Royal North Shore Hospital
Reserve Rd, St. Leonards,
NSW 2065, Australia
Country 36828 0
Australia
Phone 36828 0
+61 2 9463 2925
Fax 36828 0
+61 2 9463 2099
Email 36828 0
peter.singh@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.