NCT00518128

Brief Summary

The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 22, 2012

Status Verified

May 1, 2012

Enrollment Period

3.9 years

First QC Date

August 16, 2007

Last Update Submit

May 18, 2012

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaLeptinHomocysteineC-reactive protein

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein level

    Before and after surgery

Secondary Outcomes (1)

  • Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.

    Before and after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Surgical OSA Treatment Group: Moderate to Severe OSA patients who are unable to tolerate PAP (Positive Airway Pressure) and elect to proceed with surgical treatment (surgical cohort).

Procedure: Surgical OSA treatment

2

ACTIVE COMPARATOR

Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure).

Procedure: Positive Airway Pressure Therapy

Interventions

Surgical OSA treatmentPROCEDURE

uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension

Also known as: UPPP, GA hyoid myotomy and suspension
1
Positive Airway Pressure TherapyPROCEDURE

Continuous positive airway pressure for treatment of obstructive sleep apnea

Also known as: CPAP
2

Eligibility Criteria

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

You may qualify if:

  • Unable to tolerate PAP, supported by statement from sleep physician
  • Multilevel airway obstruction
  • Elect to proceed with surgical OSA treatment (uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension)
  • Tolerance of PAP during titration study and indication of willingness to use
  • No previous treatment of PAP except during titration study
  • Washout period of two weeks between PAP titration study and study assessment
  • Matched to surgical group patient on age, gender, race, body mass index, and OSA disease severity (apnea-hypopnea index)

You may not qualify if:

  • Pregnant women
  • Primary snoring or mild OSA (apnea-hypopnea index \< 15)
  • Known neurologic, cardiac, hepatic, or renal disorder
  • Acute illness or infection
  • Co-existing sleep disorder other than primary snoring
  • Unable to fast overnight prior to blood draw

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Department of Otolaryngology - Head and Neck Surgery

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Kezirian EJ, Malhotra A, Goldberg AN, White DP. Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery. Laryngoscope. 2010 Jul;120(7):1481-8. doi: 10.1002/lary.20946.

    PMID: 20564750DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Suspensions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Eric Kezirian, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Otolaryngology--Head and Neck Surgery

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 22, 2012

Record last verified: 2012-05

Locations

US(1)