Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The purpose of the study is to compare the effectiveness of soft palatal implants with placebo and continuous positive airway pressure treatment in obstructive sleep apnea.

Detailed Description
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Obstructive sleep apnea (OSA), frequently associated with disruptive snoring, is a prevalent disorder which is increasingly recognized by health care providers and lay people alike as an important factor in impaired daytime executive function as well as cardiovascular disease risk. Along with an increase in its recognition and diagnosis have come a growing pool of patients with milder disease and the associated challenge of ideal management. Positive airway pressure (PAP) is well established as the mainstay of treatment for OSA since it is effective at reversing daytime neurocognitive sequelae and may be a useful adjunct to therapy in those with cardiovascular disease coexisting with OSA. In patients with mild OSA, however, the response to PAP therapy appears muted, which is related in part to poor adherence to treatment. In response, a number of alternative treatments have evolved. The most recent innovation is soft palatal implants, which, in non-randomized, uncontrolled studies have demonstrated reasonable efficacy in the treatment of snoring and mild to moderate OSA. How the implants compare with standard therapy and their effect on cardiovascular variables are unknown. Because of the ease and rapidity with which this system is implanted, and because treatment effect is independent of patient compliance, there is high potential for widespread use in patients with milder OSA. We therefore are conducting a randomized, placebo-controlled clinical trial to compare the impact of palatal implants with PAP on sleep disordered breathing, daytime symptoms and blood pressure, as well as patient / bed partner acceptance.

Official Title
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A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: soft palate implant
* Other: Positive airway pressure (PAP)


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Age >18 yrs AHI 5-30 Tonsil size <50% of airway No anatomically fixed nasal stenosis BMI = 32 kg/m2 EXCLUSION CRITERIA 1. The presence of a concomitant untreated primary sleep disorder (restless legs syndrome, narcolepsy, idiopathic hypersomnia) 2. Severe daytime sleepiness (history of sleep-related motor vehicle or occupational accident) 3. Moderate to severe pulmonary disease (FEV1 <50% pred) 4. Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis) 5. Significant cardiac disease (LVEF<50%, moderate to severe valvular disease) 6. Uncontrolled hypertension >180/110 7. Renal disease (Scr > 2.5) 8. Allergy to local anesthetics used for implantation procedure. 9. Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Positive airway pressure (PAP)<br>which is air delivered by a mask worn over the nose during sleep | Other: Positive airway pressure (PAP)<br>* which is air delivered by a mask worn over the nose during sleep<br>|
| Active Comparator: outpatient surgical procedure<br>where small fabric rods are inserted into the soft palate (the fleshy portion of the roof of the mouth) to stiffen the tissues. | Device: soft palate implant<br> <br> |
| Sham Comparator: Sham surgery<br>an outpatient surgical procedure identical to #2 except that no rods are inserted into the soft palate. | Device: soft palate implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea-hypopnea index |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleepiness |  | 90 days | 
| quality of life |  | 90 days | 
| ambulatory blood pressure |  | 90 days | 
| snoring |  | 90 days |