Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea

NCT00988351 | Completed Results

• 1 other identifier: UFIRB#384-09
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea; positive airway pressure; portable monitoring; auto positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Positive Airway Pressure Adherence (Nightly Use of Treatment)

  average nightly hours of using positive airway pressure (including 0 for nights not used)

  6 weeks after starting treatment

Secondary Outcomes (4)

• Change in Epworth Sleepiness Scale

  6 weeks after starting treatment

• Change in Functional Outcomes of Sleep Questionnaire

  6 weeks at clinic

• Residual Apnea-hypopnea Index

  over first 6 weeks of treatment

• Treatment Pressure (Level of CPAP or 90th Percentile APAP)

  6 weeks clinic

Study Arms (2)

PSG CPAP titration then CPAP treatment

ACTIVE COMPARATOR

Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment

Device: Continuous positive airway pressure

Auto-Adjusting Positive Airway Pressure

ACTIVE COMPARATOR

Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.

Device: Auto-adjusting positive airway pressure treatment

Interventions

Continuous positive airway pressure DEVICE

continuous positive airway pressure determined by polysomnography titration

Also known as: CPAP

PSG CPAP titration then CPAP treatment

Auto-adjusting positive airway pressure treatment DEVICE

Pressure range 4-18 centimeters of water (cm H2O)

Also known as: AutoCPAP, APAP

Auto-Adjusting Positive Airway Pressure

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OSA, Apnea-hypopnea index \> 5/hour

You may not qualify if:

• Prior CPAP
• Uncontrolled Depression
• Moderate to Severe chronic obstructive pulmonary disease (COPD)
• Hypoventilation
• Average estimated nightly total sleep time \< 4 hours
• Shift work
• Unstable depression
• Upper airway surgery
• Uncontrolled Restless legs syndrome (RLS), narcolepsy
• Use of supplemental oxygen
• Severe congestive heart failure
• Use of nightly potent narcotics
• Severe obesity (BMI \> 40)

Sponsors & Collaborators

• North Florida Foundation for Research and Education: lead

Study Sites (1)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

Carefully selected group with male predominance

Results Point of Contact

• Title: Dr. Richard B. Berry
• Organization: Malcom Randall VA

Richard.Berry@medicine.ufl.edu

3522621575

Study Officials

• Richard B Berry, MD

  University of Florida/Malcom Randall VAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine University of Florida

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 3, 2014
• Results First Posted: November 3, 2014

Record last verified: 2014-10

Locations

US (1)