Clinical trial NCT00263770: Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea
Official title: A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic Xomed, Inc.
name: ResMed Foundation
First posted: 2005-12-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: INCLUSION CRITERIA

1. Age \>18 yrs
2. AHI 5-30
3. Tonsil size \<50% of airway
4. No anatomically fixed nasal stenosis
5. 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

Primary outcomes:
measure: apnea-hypopnea index
timeFrame: 90 days
Secondary outcomes:
measure: sleepiness
timeFrame: 90 days
measure: quality of life
timeFrame: 90 days
measure: ambulatory blood pressure
timeFrame: 90 days
measure: snoring
timeFrame: 90 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sean M. Caples, D.O.
role: PRINCIPAL_INVESTIGATOR
References: