Obstructive Sleep ApneaOPENNCT01772017
A Trial to Evaluate a Device for the Treatment of OSA and Snoring
A study testing Tongue Advancement Retainer Device in people with Obstructive Sleep Apnea and Snoring, run by Sleepy, Inc at 3 sites in 2 countries.
Trial summary
To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Snoring
- What is being tested?
- Tongue Advancement Retainer Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Senta Clinic
San Diego, California, 92120
Visalia Medical Clinic
Visalia, California, 93291
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
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)
To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Snoring
- Being tested
- Tongue Advancement Retainer Device
- Keywords
- Obstructive Sleep Apnea, OSA, Snoring, Tongue Advancement Retainer Device
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Advancement Retainer DeviceDevice
Also called Sleepy Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
| Study group | Role | What they receive |
|---|---|---|
| Device Treatment | Experimental | Tongue Advancement Retainer Device Receives: Device: Tongue Advancement Retainer Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 6 weeks
Secondary outcomes (1)
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.
Measured: Approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Sponsor decided to discontinue study for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sleepy, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Weeks, MD, Principal investigator, Senta Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772017
- Sponsor's protocol ID
- OPEN-002
- Acronym
- OPEN
- Status last verified
- Nov 2015
- First submitted
- 30 Oct 2012
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01772017
- Acronym / sponsor ID
- OPEN / OPEN-002
- Conditions
- Obstructive Sleep Apnea, Snoring
- Keywords
- Obstructive Sleep Apnea, OSA, Snoring, Tongue Advancement Retainer Device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to discontinue study for business reasons.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sleepy, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Treatment | Experimental | Device: Tongue Advancement Retainer DeviceTongue Advancement Retainer Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Aged 18-65
- 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
Key exclusion criteria (13 listed)
- • Central sleep apnea events >10% of the total events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue Advancement Retainer DeviceAlso: Sleepy Tongue Advancement Retainer DeviceTongue Advancement Retainer Device | Device | Device Treatment |
Primary outcome
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
Time frame: Approximately 6 weeks
Safety endpoint will be measured throughout the duration of the study.
1 secondary outcome
Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.
Time frame: Approximately 6 weeks
Results and safety
The study was stopped early (reason given: Sponsor decided to discontinue study for business reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
Related trials for Obstructive Sleep Apnea
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Not yet recruitingObservational study
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingPhase 2/3
Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
Sleep Apnoea, Obesity & Overweight
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Weeks, MD principal investigator
Senta Clinic
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue Advancement Retainer Device in people with Obstructive Sleep Apnea and Snoring, run by Sleepy, Inc at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decided to discontinue study for business reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events. (time frame: Approximately 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.