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Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea (CATNAP)

Primary Purpose

Lung Diseases, Sleep Apnea Syndromes, Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP) Treatment
Sham CPAP device - CPAP device with pressure delivered <1 cm H20
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Newly diagnosed with OSA on overnight polysomnogram (PSG) with RDI between 5 and 30 Score of greater than 11 on the Epworth Sleepiness Scale (ESS) on two administrations of the instrument (performed at prescreening and screening), each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness Stable medical history and no change in medications, including hypertension medications, in the 3 months prior to study entry Stable psychiatric history and no change in psychotropic medications in the 3 months prior to study entry Has access to a telephone Exclusion Criteria Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., periodic limb movement disorder (greater than 10 limb movements per hour of sleep with arousal); central sleep apnea (greater than 5 or more central apneas); insomnia; sleep hypoventilation syndrome; or narcolepsy Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA Oxygen or bi-level CPAP required for treatment of OSA Unable to return for study instructions or follow-up testing Medically unstable condition (e.g., heart attack, congestive heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the 3 months prior to study entry Regular use (greater than 3 times per week) of sedative, hypnotic, or alerting medications (such as Modafinil) in the 3 months prior to study entry Chronic nasal congestion that would prevent the use of a nasal mask, in the 3 months prior to study entry History of automobile accidents due to excessive daytime sleepiness Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer Night shift worker regularly experiencing jet lag, or a history of irregular work schedules in the 6 months prior to study entry Regular use of alcohol as determined by answering yes to one or more of the questions on the CAGE questionnaire (i.e., alcohol dependent) Recent or recurring history of substance abuse leading to tolerance or dependence Pregnant; women must either be postmenopausal or confirmed not pregnant by a urine pregnancy test Unable to perform study tests, e.g., inability to communicate verbally; inability to write and read in English; less than a 5th grade reading level (evaluated using Flesch-Kincaid assessment); visual impairment; hearing impairment; cognitive impairment (e.g., previous head injury); or upper extremity motor deficit (e.g., previous stroke or spinal cord injury) Residing with an individual who is currently using CPAP treatment

Sites / Locations

  • National Jewish Medical and Research Center (NJC)
  • Emory University School of Medicine (EMO)
  • North Shore-Long Island Jewish Health System (LIJ)
  • New York University Medical School
  • University of Western Ontario (UWO)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Treatment

Sham/Placebo Treatment

Arm Description

Continuous Positive Airway Pressure Treatment

Ineffective sham continuous positive airway pressure device with leak in interface to <1.0 cm H2O and resistance in motor to simulate normal operating noise and no compensation for leak.

Outcomes

Primary Outcome Measures

Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment
The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5-30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.

Secondary Outcome Measures

Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale
Change in the score from baseline to 8 weeks treatment, controlling for baseline in the self-rated 8 item measure of daytime sleepiness with a range from 0 - 24. Lower values indicting less daytime sleepiness
Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment
Change in mean arterial pressure (MAP) value from baseline to 8 weeks treatment, controlling for baseline, measured by 48 hours ambulatory blood pressure device - Space Laboratories
Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the POMS is a reliable and valid measure of mood states that consists of 65 adjectives on which subjects' rate themselves as they feel "today" using a five-point scale. There are six mood or affective states on this test derived through factor analysis: Tension-Anxiety (score range 0-36), Depression-Dejection (score range 0 - 60), Anger-Hostility (score range 0-48), Vigor-Activity (score range 0-32), Fatigue-Inertia (score range 0-28), and Confusion-Bewilderment (score range 0-28). There is also a summary Total Mood Disturbance (TMD) score that gives a Total estimate of affective state score range 0-200). Higher scores indicate greater disability.
Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the PVT is an objective assessment of sleepiness and measures decrements in neurobehavioral performance due to sleepiness, i.e., ability to sustain attention and respond in a timely manner to salient signals.(7) The PVT yields five highly informative metrics on the capacity for sustained attention and vigilance performance: frequency of lapses, duration of lapse domain, optimum response time, vigilance decrement function, false response frequency. We applied this conceptually valid, relatively short duration, reliable task with known psychometric properties and minimal practice/learning curves to document attentional lapses (response times > 500 msec) in performance.
Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.
Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.

Full Information

First Posted
August 12, 2004
Last Updated
June 26, 2017
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Respironics Sleep and Respiratory Foundation, Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00089752
Brief Title
Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
Acronym
CATNAP
Official Title
Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Respironics Sleep and Respiratory Foundation, Cephalon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea (OSA) following continuous positive airway pressure (CPAP) treatment.
Detailed Description
BACKGROUND: OSA is characterized as mild, moderate, or severe, according to the number of respiratory disturbances per hour of sleep (RDI), as defined by the American Academy of Sleep Medicine. CPAP is the primary treatment for sleep apnea. The column of pressure delivered to the upper airway by this device immediately eliminates the respiratory disturbances when it is applied. There is evidence from randomized controlled studies that CPAP also improves functional status, and the key manifestation of OSA, including excessive daytime sleepiness, in individuals with severe OSI (i.e., RDI greater than 30). However, there has been limited research exploring improvement in functional status in individuals with less severe OSA (i.e., those with mild OSA and RDI of 5-15 or moderate OSA and RDI of 16-30). The large placebo effect that has been reported in controlled studies of OSA-associated functional outcomes mandates the need for a placebo in studies evaluating the true impact of this treatment. Results from the three randomized controlled studies in milder OSA that have examined this issue have been equivocal, principally because of serious methodological limitations. It remains unclear whether CPAP treatment improves daily functioning in those with milder OSA (RDI 5-30). This is a critical issue as this level of disease severity represents the largest segment of OSA and comprises 15% of the U.S. population. DESIGN NARRATIVE: Using Granger's model of functional assessment, this study will examine whether functional status improves in participants with milder OSA following CPAP treatment. The study will employ a randomized, placebo-controlled, parallel study design, and will use a sham CPAP device as the placebo in participants with significant daytime sleepiness. The study will test the hypothesis that the change in functional status (measured by the Functional Outcomes of Sleep Questionnaire) after 8 weeks of treatment will be greater for participants treated with active CPAP compared to the placebo. Secondary aims of the study include examining whether CPAP also improves daytime sleepiness, and determining whether CPAP can reduce nocturnal blood pressure to lower the risk for stroke and hypertension linked to OSA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Sleep Apnea Syndromes, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
Continuous Positive Airway Pressure Treatment
Arm Title
Sham/Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
Ineffective sham continuous positive airway pressure device with leak in interface to <1.0 cm H2O and resistance in motor to simulate normal operating noise and no compensation for leak.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP) Treatment
Other Intervention Name(s)
Positive Airway Pressure
Intervention Description
CPAP device used at night
Intervention Type
Device
Intervention Name(s)
Sham CPAP device - CPAP device with pressure delivered <1 cm H20
Intervention Description
Sham CPAP device used at night
Primary Outcome Measure Information:
Title
Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment
Description
The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5-30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale
Description
Change in the score from baseline to 8 weeks treatment, controlling for baseline in the self-rated 8 item measure of daytime sleepiness with a range from 0 - 24. Lower values indicting less daytime sleepiness
Time Frame
Measured at Baseline and Week 8 of treatment in ITT sample
Title
Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment
Description
Change in mean arterial pressure (MAP) value from baseline to 8 weeks treatment, controlling for baseline, measured by 48 hours ambulatory blood pressure device - Space Laboratories
Time Frame
Measured at Baseline and Week 8 treatment in the ITT sample
Title
Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States
Description
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the POMS is a reliable and valid measure of mood states that consists of 65 adjectives on which subjects' rate themselves as they feel "today" using a five-point scale. There are six mood or affective states on this test derived through factor analysis: Tension-Anxiety (score range 0-36), Depression-Dejection (score range 0 - 60), Anger-Hostility (score range 0-48), Vigor-Activity (score range 0-32), Fatigue-Inertia (score range 0-28), and Confusion-Bewilderment (score range 0-28). There is also a summary Total Mood Disturbance (TMD) score that gives a Total estimate of affective state score range 0-200). Higher scores indicate greater disability.
Time Frame
Measured at Baseline and Week 8 treatment in the ITT sample
Title
Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test
Description
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the PVT is an objective assessment of sleepiness and measures decrements in neurobehavioral performance due to sleepiness, i.e., ability to sustain attention and respond in a timely manner to salient signals.(7) The PVT yields five highly informative metrics on the capacity for sustained attention and vigilance performance: frequency of lapses, duration of lapse domain, optimum response time, vigilance decrement function, false response frequency. We applied this conceptually valid, relatively short duration, reliable task with known psychometric properties and minimal practice/learning curves to document attentional lapses (response times > 500 msec) in performance.
Time Frame
Baseline and 8 weeks of treatment in the ITT sample
Title
Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical
Description
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.
Time Frame
Baseline and Week 8 of treatment in ITT sample.
Title
Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component
Description
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.
Time Frame
Baseline and after 8 weeks of treatment in ITT sample

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Newly diagnosed with OSA on overnight polysomnogram (PSG) with RDI between 5 and 30 Score of greater than 11 on the Epworth Sleepiness Scale (ESS) on two administrations of the instrument (performed at prescreening and screening), each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness Stable medical history and no change in medications, including hypertension medications, in the 3 months prior to study entry Stable psychiatric history and no change in psychotropic medications in the 3 months prior to study entry Has access to a telephone Exclusion Criteria Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., periodic limb movement disorder (greater than 10 limb movements per hour of sleep with arousal); central sleep apnea (greater than 5 or more central apneas); insomnia; sleep hypoventilation syndrome; or narcolepsy Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA Oxygen or bi-level CPAP required for treatment of OSA Unable to return for study instructions or follow-up testing Medically unstable condition (e.g., heart attack, congestive heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the 3 months prior to study entry Regular use (greater than 3 times per week) of sedative, hypnotic, or alerting medications (such as Modafinil) in the 3 months prior to study entry Chronic nasal congestion that would prevent the use of a nasal mask, in the 3 months prior to study entry History of automobile accidents due to excessive daytime sleepiness Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer Night shift worker regularly experiencing jet lag, or a history of irregular work schedules in the 6 months prior to study entry Regular use of alcohol as determined by answering yes to one or more of the questions on the CAGE questionnaire (i.e., alcohol dependent) Recent or recurring history of substance abuse leading to tolerance or dependence Pregnant; women must either be postmenopausal or confirmed not pregnant by a urine pregnancy test Unable to perform study tests, e.g., inability to communicate verbally; inability to write and read in English; less than a 5th grade reading level (evaluated using Flesch-Kincaid assessment); visual impairment; hearing impairment; cognitive impairment (e.g., previous head injury); or upper extremity motor deficit (e.g., previous stroke or spinal cord injury) Residing with an individual who is currently using CPAP treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri Weaver
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
Facility Information:
Facility Name
National Jewish Medical and Research Center (NJC)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Emory University School of Medicine (EMO)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
North Shore-Long Island Jewish Health System (LIJ)
City
Long Island City
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York University Medical School
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Western Ontario (UWO)
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Petition of Principal Investigator with document outlining purpose of secondary analysis and use of the data, which is then reviewed with co-investigators for overall approval.
Citations:
PubMed Identifier
22837377
Citation
Weaver TE, Mancini C, Maislin G, Cater J, Staley B, Landis JR, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Gurubhagavatula I, Kuna ST. Continuous positive airway pressure treatment of sleepy patients with milder obstructive sleep apnea: results of the CPAP Apnea Trial North American Program (CATNAP) randomized clinical trial. Am J Respir Crit Care Med. 2012 Oct 1;186(7):677-83. doi: 10.1164/rccm.201202-0200OC. Epub 2012 Jul 26.
Results Reference
result
PubMed Identifier
20175410
Citation
Rodway GW, Weaver TE, Mancini C, Cater J, Maislin G, Staley B, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Kuna ST. Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep. 2010 Feb;33(2):260-6. doi: 10.1093/sleep/33.2.260.
Results Reference
derived

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Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea

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