Clinical trial NCT00307957: Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
Official title: Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Daytime Sleepiness
Pillar Palatal Implants
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Medtronic Xomed, Inc.
First posted: 2006-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daytime Sleepiness (ESS)
measure: Apnea/Hypopnea Index (AHI)
Secondary outcomes:
measure: Sleep Related Quality of Life (FOSQ)
measure: Reaction Time Testing (PVT)
measure: Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University of Indiana Medical Center
state: Indiana
city: Cincinnati
country: United States
facility: University Ear, Nose and Throat Specialists
state: Ohio
city: Milwaukee
country: United States
facility: Department of OTO-HNS Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University Ear, Nose and Throat Specialists
name: David L Steward, MD
role: PRINCIPAL_INVESTIGATOR
References: