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

Obstructive Sleep Apnea Clinical Trial

Official title:

Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988351
• Other study ID #: UFIRB#384-09
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: October 30, 2014
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: North Florida Foundation for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airway pressure
continuous positive airway pressure determined by polysomnography titration
• Auto-adjusting positive airway pressure treatment
Pressure range 4-18 centimeters of water (cm H2O)

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
North Florida Foundation for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Epworth Sleepiness Scale	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	No
Secondary	Change in Functional Outcomes of Sleep Questionnaire	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	No
Secondary	Residual Apnea-hypopnea Index	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	No
Secondary	Treatment Pressure (Level of CPAP or 90th Percentile APAP)	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	No