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

This study is currently recruiting participants.
Verified October 2012 by North Florida Foundation for Research and Education
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 29, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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 ]

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

Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Estimated 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 CPAP titration with polysomnography (PSG)followed by CPAP Treatment
 Device: Continuous positive airway pressure
continuous positive airway pressure determined by polysomnography titration
Other Name: CPAP
Active Comparator: Auto-Positive APAP treatment
Following diagnosis of obstructive sleep apnea patients will be treated with auto-adjusting positive airway pressure 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) and performs psychomotor vigilance testing (PVT). 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, PVT, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988351

Contacts
Contact: Richard B Berry, MD 3522621575 berryrb@medicine.ufl.edu
Contact: Peruvemba S Sriram, MD 3523761611 ext 6243 Peruvemba.Sriram@va.gov

Locations
United States, Florida
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Richard B Berry, MD     352-262-1575     berryrb@medicine.ufl.edu    
Contact: Joy Mitchell, CCRC     3523761611 ext 5832     Joy.Mitchell@va.gov    
Sub-Investigator: Peruvemba S Sriram, MD            
Principal Investigator: Richard B Berry, M.D.            
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
Last Updated: October 29, 2012
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
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
 Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013