NCT00205543

Brief Summary

In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

4.4 years

First QC Date

September 15, 2005

Last Update Submit

June 19, 2012

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneaairway obstructionsleep-disordered breathing

Outcome Measures

Primary Outcomes (1)

  • sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months

    6-12mo

Secondary Outcomes (2)

  • Operative time

    immediate

  • Procedure cost

    immediate

Study Arms (3)

1

EXPERIMENTAL

suture palate after resection

Procedure: uvulopalatopharyngoplasty with or without sutures

2

EXPERIMENTAL

suture one side of palate afer resection

Procedure: uvulopalatopharyngoplasty with or without sutures

3

EXPERIMENTAL

no sutures in palate after resection

Procedure: uvulopalatopharyngoplasty with or without sutures

Interventions

uvulopalatopharyngoplasty with or without suturesPROCEDURE

standard UPPP

123

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sleep-study documented obstructive sleep apnea
  • sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)
  • age \> 21

You may not qualify if:

  • previous palate surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University

Richmond, Virginia, 23298-0146, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAirway ObstructionSleep Apnea Syndromes

Interventions

Sutures

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory Insufficiency

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Evan R Reiter, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 20, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

US(1)