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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 12, 2007

Status Verified

December 1, 2007

First QC Date

March 27, 2006

Last Update Submit

December 10, 2007

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaDaytime SleepinessPillar Palatal Implants

Outcome Measures

Primary Outcomes (2)

  • Daytime Sleepiness (ESS)

  • Apnea/Hypopnea Index (AHI)

Secondary Outcomes (3)

  • Sleep Related Quality of Life (FOSQ)

  • Reaction Time Testing (PVT)

  • Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)

Interventions

Pillar Palatal ImplantsDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Indiana Medical Center

Indianapolis, Indiana, United States

Location

University Ear, Nose and Throat Specialists

Cincinnati, Ohio, 45267-0528, United States

Location

Department of OTO-HNS Medical College of Wisconsin

Milwaukee, Wisconsin, 53022, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • David L Steward, MD

    University Ear, Nose and Throat Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

October 1, 2005

Study Completion

October 1, 2006

Last Updated

December 12, 2007

Record last verified: 2007-12

Locations

US(3)