- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00307957
Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States
- University of Indiana Medical Center
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267-0528
- University Ear, Nose and Throat Specialists
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53022
- Department of OTO-HNS Medical College of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Daytime Sleepiness (ESS)
|
Apnea/Hypopnea Index (AHI)
|
Secondary Outcome Measures
Outcome Measure |
---|
Sleep Related Quality of Life (FOSQ)
|
Reaction Time Testing (PVT)
|
Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-08-14-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
Clinical Trials on Pillar Palatal Implants
-
Medtronic Xomed, Inc.MedtronicTerminatedNasal Alar Collapse, BilateralUnited States
-
Medtronic Xomed, Inc.MedtronicTerminatedObstructive Sleep Apnea (OSA)United States
-
University of PittsburghBaylor College of Medicine; Centers for Disease Control and PreventionCompletedAdult Influenza Vaccinations | Adult PPSV Vaccinations | Adult Tdap/Td VaccinationsUnited States
-
Korean Medicine Hospital of Pusan National UniversityCompletedOveractive Bladder | Lower Urinary Tract Symptoms | Hyperthermia | Urinary Frequency or Urgency Adverse EventKorea, Republic of
-
University of JordanCompleted
-
Damascus UniversityCompletedMaxillary ConstrictionSyrian Arab Republic
-
Universidade Estadual Paulista Júlio de Mesquita...RecruitingWound Healing | Palate; WoundBrazil
-
University of Alabama at BirminghamActive, not recruitingGingival Recession | Palate; WoundUnited States
-
Université de MontréalMcGill UniversityCompleted
-
Université de MontréalUniversity of Sao PauloCompleted