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

October 30, 2014 updated by: Richard Berry, North Florida Foundation for Research and Education

Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical conditions. Screening of the sleep questionnaire and the patient's medical record is part of routine care to identify patients needing a diagnostic PSG and/or an attended titration. At the end of the class, participation in the current study will be offered the patients. Those signifying interest in being part of the research study and meeting inclusion and exclusion criteria will be contacted to participate in the study. Once they sign an informed consent they will be randomized to one of the two clinical pathways.

METHODS: Study visits:

Before informed consent (routine clinical care)

  1. Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA treatment). Patients complete screening sleep and medical history questionnaires.
  2. Determination of patient interest in participating in the current study and review of inclusion/exclusion criteria

After informed consent

  1. PM study
  2. Randomization if the Portable monitoring (PM) study is diagnostic of OSA. If not, the patient will be offered a diagnostic PSG. If this is positive, they will have APAP treatment. If both the PM and PSG are negative for OSA the patient exits the study but will be followed in sleep clinic.
  3. PSG for CPAP titration (PSG arm only).
  4. CPAP/APAP setup - patient fills out Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). The same Research coordinator/Respiratory therapist will setup the units, fit masks, and instruct the patients on the use of their device. Patients being treated with CPAP or APAP will be in separate classes.
  5. Telephone contact within 7 days of setup with early intervention for PAP problems if needed.
  6. Clinic visit 6 weeks after starting treatment: download objective adherence, ESS, FOSQ, and PAP satisfaction questionnaire.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OSA, Apnea-hypopnea index > 5/hour

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PSG CPAP titration then CPAP treatment
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
continuous positive airway pressure determined by polysomnography titration
Other Names:
  • CPAP
ACTIVE_COMPARATOR: Auto-Adjusting Positive Airway Pressure
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
Pressure range 4-18 centimeters of water (cm H2O)
Other Names:
  • APAP
  • AutoCPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Airway Pressure Adherence (Nightly Use of Treatment)
Time Frame: 6 weeks after starting treatment
average nightly hours of using positive airway pressure (including 0 for nights not used)
6 weeks after starting treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Epworth Sleepiness Scale
Time Frame: 6 weeks after starting treatment
Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.
6 weeks after starting treatment
Change in Functional Outcomes of Sleep Questionnaire
Time Frame: 6 weeks at clinic
The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.
6 weeks at clinic
Residual Apnea-hypopnea Index
Time Frame: over first 6 weeks of treatment
The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.
over first 6 weeks of treatment
Treatment Pressure (Level of CPAP or 90th Percentile APAP)
Time Frame: 6 weeks clinic
The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.
6 weeks clinic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Florida Foundation for Research and Education

Investigators

  • Principal Investigator: Richard B Berry, MD, University of Florida/Malcom Randall VAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (ESTIMATE)

October 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFIRB#384-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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