Measuring Effectiveness in Sleep Apnea Surgery

University of California San Francisco (UCSF)

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: Surgical OSA treatment; Procedure: Positive Airway Pressure Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00518128

RR024130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Active Comparator group

Description:

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).

Treatment:

Procedure: Surgical OSA treatment

2

Active Comparator group

Description:

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

Treatment:

Procedure: Positive Airway Pressure Therapy