Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00263770
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	N/A
Start date	December 2005
Completion date	October 2007

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.