NCT00507078

Brief Summary

Recent years have witnessed major advances in the understanding of the hormonal, metabolic, and biochemical changes that occur in obstructive sleep apnea (OSA). This project evaluates the biomarkers that measure the most significant health impacts of this disorder and creates a specimen bank that will facilitate evaluations of additional biomarkers in the future.

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 Jun 2005

Typical duration 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

June 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

First QC Date

July 23, 2007

Last Update Submit

May 18, 2012

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaLeptinHomocysteineC-reactive Protein

Outcome Measures

Primary Outcomes (1)

  • Leptin, homocysteine, and C-reactive protein levels.

    Before and after surgery

Interventions

Surgical treatment for OSAPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • OSA group is adults with moderate or severe OSA (apnea \>= 15 based on preoperative sleep study) undergoing surgical treatment. Assessment is done prior to surgery.
  • Control group is overweight (body mass \>25) adults without OSA (apnea-hypopnea index \<5 based on sleep study) or other sleep disorders. Assessment is prior to treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eric Kezirian, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director of Sleep Surgery

Study Record Dates

First Submitted

July 23, 2007

First Posted

July 25, 2007

Study Start

June 1, 2005

Study Completion

June 1, 2007

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

US(1)