Obstructive Sleep ApneaPhase 4FASTNCT01611779
FAST as a Treatment for Obstructive Sleep Apnea
A Phase 4 study testing Encore Tongue Suspension System in people with Obstructive Sleep Apnea, run by Siesta Medical, Inc. at 1 site in United States.
Trial summary
The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Encore Tongue Suspension System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure
- Age >/= 20 and >/= 65
- Body Mass Index ,/= 32 (kg/m^2)
- Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP
- Signed informed consent to participate in this study
Who cannot join
- Prior OSA surgery
- Active systemic infection
- Allergy to any medication used during implantation
- Previous history of neck or upper respiratory tract
- Significant dysphagia or speech disorder
- Anatomical
Show all 14Show fewer
- Identified obvious palatal stenosis
- Enlarged tonsils (3+)
- Anatomy unable to accommodate the implant
- Other
- Other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and the procedures and evaluations pre- and post-treatment
- Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
- Unable and/or not willing to comply with treatment follow-up requirements
- Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
The Atlanta Snoring and Sleep Disorders Institute
Atlanta, Georgia, 30342
About this study
Official title: Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea
The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).
Read the detailed description
Obstructive sleep apnea (OSA) has become a major health problem in the United States. With prevalence in middle-aged adults of 2-4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure.
The first and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing apnea-hypopnea index (AHI) is used properly. However, the nasal mask required for CPAP during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have shown that only 58-8-% of patient accept CPAP therapy and further 65-90% of these patients exhibit long-term compliance with CPAP.
It is widely accepted that the region behind the tongue is a major site of collapse during obstructive sleep apnea. In fact there are many surgical procedures performed currently to address tongue based collapse. These include RF ablation of the tongue base, genioglossus advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension.
The current study is designed to evaluate the feasibility of tongue stabilization, and assess safety and treatment of the tongue stabilization.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Encore Tongue Suspension System
- Keywords
- obstructive sleep apnea, tongue suspension
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encore Tongue Suspension SystemDevice
Also called Tongue suspension, FG0002
The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
| Study group | Role | What they receive |
|---|---|---|
| Tongue suspension | Experimental | Tongue-based suspension Receives: Device: Encore Tongue Suspension System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Place the Implant and Stabilize the Tongue
Ability to place the implant and stabilize the tongue
Measured: Up to 7 weeks after the procedure
Number of Participants Experiencing Complications
Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.
Measured: 3 months
Secondary outcomes (4)
Apnea Hypopnea Index
0 to >30/hour (high value represents worse outcome)
Measured: Baseline, 3, and 12 months
Functional Outcomes and Sleep Questionnaire (FOSQ)
Questionnaire: 0 to 120 (high value represents better outcome)
Measured: Baseline, 1, 3, 12 months
Snoring Scale (VAS)
0 to 10 (high value represents worse outcome)
Measured: Baseline, 1 week; 1 month, 3 months, 12 months
Epworth Sleeping Scale (ESS)
0 to 24 (high value represents worse outcome)
Measured: Baseline, 1, 3, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siesta Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Goldberg, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611779
- Sponsor's protocol ID
- 2011
- Acronym
- FAST
- Status last verified
- Jan 2017
- First submitted
- 29 May 2012
- Last updated
- 24 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01611779
- Acronym / sponsor ID
- FAST / 2011
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, tongue suspension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Siesta Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).
Detailed description
Obstructive sleep apnea (OSA) has become a major health problem in the United States. With prevalence in middle-aged adults of 2-4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure.
The first and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing apnea-hypopnea index (AHI) is used properly. However, the nasal mask required for CPAP during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have shown that only 58-8-% of patient accept CPAP therapy and further 65-90% of these patients exhibit long-term compliance with CPAP.
It is widely accepted that the region behind the tongue is a major site of collapse during obstructive sleep apnea. In fact there are many surgical procedures performed currently to address tongue based collapse. These include RF ablation of the tongue base, genioglossus advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension.
The current study is designed to evaluate the feasibility of tongue stabilization, and assess safety and treatment of the tongue stabilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tongue suspension | Experimental | Device: Encore Tongue Suspension SystemTongue-based suspension |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure
- Age >/= 20 and >/= 65
- Body Mass Index ,/= 32 (kg/m^2)
- Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP
- Signed informed consent to participate in this study
Key exclusion criteria (14 listed)
- Prior OSA surgery
- Active systemic infection
- Allergy to any medication used during implantation
- Previous history of neck or upper respiratory tract
- Significant dysphagia or speech disorder
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 |
|---|---|---|
| Encore Tongue Suspension SystemAlso: Tongue suspension, FG0002The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw. | Device | Tongue suspension |
Primary outcome
Place the Implant and Stabilize the Tongue
Time frame: Up to 7 weeks after the procedure
Ability to place the implant and stabilize the tongue
Number of Participants Experiencing Complications
Time frame: 3 months
Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.
4 secondary outcomes
Apnea Hypopnea Index
Time frame: Baseline, 3, and 12 months
Functional Outcomes and Sleep Questionnaire (FOSQ)
Time frame: Baseline, 1, 3, 12 months
Snoring Scale (VAS)
Time frame: Baseline, 1 week; 1 month, 3 months, 12 months
Epworth Sleeping Scale (ESS)
Time frame: Baseline, 1, 3, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrew Goldberg, MD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Encore Tongue Suspension System in people with Obstructive Sleep Apnea, run by Siesta Medical, Inc. at 1 site in United States.
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 5 inclusion and 14 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Place the Implant and Stabilize the Tongue (time frame: Up to 7 weeks after the procedure). The study lists 2 primary outcomes in all. 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 Feb 2017.