View Clinical Trial (Medical Research Study)
Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA
| City: |
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Gainesville |
| State: |
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Florida |
| Zip Code: |
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32608 |
| Conditions: |
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Obstructive Sleep Apnea |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00988351 |
| Primary Contact: |
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Principal Investigator
Richard B Berry, MD
University of Florida/Malcom Randall VAMC
Richard B Berry, MD
Phone: 3522621575
Email: berryrb@medicine.ufl.edu
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| Backup Contact: |
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Email: Peruvemba.Sriram@va.gov
Peruvemba S Sriram, MD
Phone: 3523761611 ext. 6243
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| Location Contact: |
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Gainesville, Florida 32608
United States
Richard B Berry, MD
Phone: 352-262-1575
Email: berryrb@medicine.ufl.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
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