Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT00307957
Brief Summary:
The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.
Detailed Description:
Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group.
In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.
Study:
NCT00307957
Study Brief:
Protocol Section:
NCT00307957