Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Berry, North Florida Foundation for Research and Education
ClinicalTrials.gov Identifier:
NCT00988351
First received: October 1, 2009
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: Continuous positive airway pressure
Device: Auto-adjusting positive airway pressure treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA

Resource links provided by NLM:


Further study details as provided by North Florida Foundation for Research and Education:

Primary Outcome Measures:
  • Positive Airway Pressure Adherence (Nightly Use of Treatment) [ Time Frame: 6 weeks after starting treatment ] [ Designated as safety issue: No ]
    average nightly hours of using positive airway pressure (including 0 for nights not used)


Secondary Outcome Measures:
  • Change in Epworth Sleepiness Scale [ Time Frame: 6 weeks after starting treatment ] [ Designated as safety issue: No ]
    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.

  • Change in Functional Outcomes of Sleep Questionnaire [ Time Frame: 6 weeks at clinic ] [ Designated as safety issue: No ]
    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.

  • Residual Apnea-hypopnea Index [ Time Frame: over first 6 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Treatment Pressure (Level of CPAP or 90th Percentile APAP) [ Time Frame: 6 weeks clinic ] [ Designated as safety issue: No ]
    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.


Enrollment: 156
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • AutoCPAP
  • APAP

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.
  Eligibility

Ages Eligible for Study:   21 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988351

Locations
United States, Florida
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
North Florida Foundation for Research and Education
Investigators
Principal Investigator: Richard B Berry, MD University of Florida/Malcom Randall VAMC
  More Information

No publications provided

Responsible Party: Richard Berry, Professor of Medicine University of Florida, North Florida Foundation for Research and Education
ClinicalTrials.gov Identifier: NCT00988351     History of Changes
Other Study ID Numbers: UFIRB#384-09
Study First Received: October 1, 2009
Results First Received: March 23, 2014
Last Updated: October 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Florida Foundation for Research and Education:
sleep apnea
positive airway pressure
portable monitoring
auto positive airway pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014