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Slow enrollment
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tongue suspension | Experimental | Tongue-based suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encore Tongue Suspension System | Device | The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Place the Implant and Stabilize the Tongue | Ability to place the implant and stabilize the tongue | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index | 0 to >30/hour (high value represents worse outcome) | Baseline, 3, and 12 months |
| Functional Outcomes and Sleep Questionnaire (FOSQ) | Questionnaire: 0 to 120 (high value represents better outcome) |
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Inclusion Criteria:
Exclusion Criteria:
Anatomical
Other
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Goldberg, MD | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Atlanta Snoring and Sleep Disorders Institute | Atlanta | Georgia | 30342 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tongue Suspension | Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with obstructive sleep apnea were enrolled in the trial. Subjects meeting the inclusion and exclusion criteria were invited to participate in the trial. Subjects were treated with the the Encore System, and followed at 1 week, and then at 1, 3, and 12 months.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tongue Suspension | Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Place the Implant and Stabilize the Tongue | Ability to place the implant and stabilize the tongue | Posted | Count of Participants | Participants | Up to 7 weeks after the procedure |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tongue Suspension | Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kolber | Siesta Medical, Inc. | 408-320-9424 | mkolber@siestamedical.com |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Baseline, 1, 3, 12 months |
| Snoring Scale (VAS) | 0 to 10 (high value represents worse outcome) | Baseline, 1 week; 1 month, 3 months, 12 months |
| Epworth Sleeping Scale (ESS) | 0 to 24 (high value represents worse outcome) | Baseline, 1, 3, 12 months |
| Participants |
|
| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Prior OSA Surgery | Count of Participants | Participants |
|
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| Primary | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | Apnea Hypopnea Index | 0 to >30/hour (high value represents worse outcome) | Three (3) of 5 subjects returned for 3 month follow-up and 2 of 5 subjects returned for the 12 month follow-up. | Posted | Mean | Standard Deviation | events/hour | Baseline, 3, and 12 months |
|
|
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| Secondary | Functional Outcomes and Sleep Questionnaire (FOSQ) | Questionnaire: 0 to 120 (high value represents better outcome) | Four (4) of 5 total subjects had data at baseline and follow-up data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1, 3, 12 months |
|
|
|
| Secondary | Snoring Scale (VAS) | 0 to 10 (high value represents worse outcome) | Four (4) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 3 had follow-up data at 3 months, and 2 had follow-up data at 12 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week; 1 month, 3 months, 12 months |
|
|
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| Secondary | Epworth Sleeping Scale (ESS) | 0 to 24 (high value represents worse outcome) | Five (5) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 4 had follow-up data at 3 months, and 2 had follow-up data at 12 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1, 3, 12 months |
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| 0 |
| 5 |
| 1 |
| 5 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
|
| 12 months |
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| Title | Measurements |
|---|
|
| 12 months |
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| 1 month |
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| 3 months |
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| 12 months |
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| 3 months |
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| 12 months |
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