Obstructive Sleep Apnea Clinical Trial
— FASTOfficial title:
Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea
Verified date | June 2012 |
Source | Siesta Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 2013 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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/m2) - 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 Exclusion Criteria: - 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 - 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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Atlanta Snoring and Sleep Disorders Institute | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Siesta Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to place the implant and stabilize the tongue | Ability to place the implant and stibilize the tongue | Up to 7 weeks after the procedure | No |
Primary | Complications | Evaluate safety of the device | 3 months | Yes |
Secondary | Apnea hypopnea index | 0 to >30/hour (high value represents worse outcome) | 3 and 12 months | No |
Secondary | Functional Outcomes and Sleep Questionnaire (FOSQ) | 0 to 120 (high value represents better outcome) | 1, 3, 12 month | No |
Secondary | Snoring Scale (VAS) | 0 to 10 (high value represents worse outcome) | 1 week; 1, 3, 12 months | Yes |
Secondary | Epworth Sleeping Scale (ESS) | 0 to 24 (high value represents worse outcome) | 1, 3, 12 months | No |
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