Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307957
• Other study ID #: 05-08-14-1
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2006
• Last updated: December 10, 2007
• Start date: October 2005
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Body Mass Index equal to 32 or less

• Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30

• Symptoms of daytime sleepiness

Exclusion Criteria:

• Septal deviation or nasal obstruction

• Nasal polyps

• Severe seasonal allergies

• Soft palate length insufficient to accommodate implants

• Fujita Modified Mallampati Class 3

• Large tonsils

• Lingual tonsil hypertrophy

• Hypopharyngeal obstruction

• Previous pharyngeal surgery

• Previous upper respiratory tract cancer or radiation therapy

• Active respiratory tract infection

• Dysphagia or speech disorder

• Neurologic disorder

• Unstable psychiatric disorder

• Pregnant or breastfeeding

• History of falling asleep driving or MVA due to sleepiness

• Currently on CPAP therapy or other device for OSA

• Other sleep disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Pillar Palatal Implants

Locations

Country	Name	City	State
United States	University Ear, Nose and Throat Specialists	Cincinnati	Ohio
United States	University of Indiana Medical Center	Indianapolis	Indiana
United States	Department of OTO-HNS Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Medtronic Xomed, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime Sleepiness (ESS)
Primary	Apnea/Hypopnea Index (AHI)
Secondary	Sleep Related Quality of Life (FOSQ)
Secondary	Reaction Time Testing (PVT)
Secondary	Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)

External Links

•   Manufacturer's website for more information on Pillar Implants