Measuring Effectiveness in Sleep Apnea Surgery

Obstructive Sleep Apnea Clinical Trial

Official title:

Measuring Effectiveness in Sleep Apnea Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518128
• Other study ID #: RR024130
• Status: Completed
• Phase: N/A
• First received: August 16, 2007
• Last updated: May 18, 2012
• Start date: July 2007
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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. We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and PAP treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Surgical Group)

• 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)

Inclusion Criteria (Comparison Group-PAP)

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Surgical OSA treatment
uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension
• Positive Airway Pressure Therapy
Continuous positive airway pressure for treatment of obstructive sleep apnea

Locations

Country	Name	City	State
United States	UCSF Department of Otolaryngology - Head and Neck Surgery	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein level		Before and after surgery	No
Secondary	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	No