search
Back to results

A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea (CPAPPs)

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-driven intervention
Usual Care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, adherence

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Obstructive Sleep Apnea (defined by Apnea-hypopnea index [AHI] > 5 per hour; with hypopneas defined as greater than 30% reduction in airflow with 4 or greater drop in oxygen saturation). AHI will be determined by full night or split-night polysomnography.
  2. Age range 21 - 85 years old.
  3. Stable medical history and no change in medications, including anti-hypertensive and thyroid replacement, in the previous 4 months.
  4. No regular use (> 3 times/week) of sedative or hypnotic medications in the last 4 months.

Exclusion Criteria:

  1. Central sleep apnea (central apnea index > 5 per hour and >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
  2. Complex sleep apnea or CPAP emergent central apnea (Central apnea index > 5 per hour during CPAP titration with >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
  3. Requiring oxygen or bi-level positive airway pressure for treatment of OSA or hypoventilation.
  4. Decompensated cardiac (heart failure or angina) or pulmonary (severe COPD or uncontrolled asthma) disease
  5. Chronic narcotic use
  6. Nasal obstruction (nasal congestion score > 15) or enlarged tonsils
  7. Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodic limb movement disorder [ 15 limb movements/hour of sleep with arousal], central sleep apnea [ 50% of apneas on diagnostic PSG are central apneas], insomnia, obesity hypoventilation syndrome, or narcolepsy).
  8. Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other surgery for OSA.
  9. Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months.
  10. Routine consumption of more than 2 alcoholic beverages per day.
  11. Recent or recurring history of recreational drug use leading to tolerance or dependence.
  12. Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment).

Sites / Locations

  • Southern Arizona VA Health Care System, Tucson, AZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation).

Usual care

Outcomes

Primary Outcome Measures

Functional Outcomes of Sleep Questionnaire (FOSQ)

Secondary Outcome Measures

CPAP adherence
Patient Activation Measure (PAM) survey assessment tool
Self efficacy measure for sleep apnea
Psychomotor vigilance test
Patient acceptability of peer-based intervention
Epworth sleepiness score

Full Information

First Posted
June 15, 2010
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT01164683
Brief Title
A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea
Acronym
CPAPPs
Official Title
A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and even death. The investigators plan to improve CPAP adherence in veterans through their interactions with peers who have successfully adopted CPAP therapy. Such "peer-buddies" may promote the well-being of veterans while remaining highly cost-effective when compared to healthcare providers. Our strategy is grounded on the rationale that veterans as a group are ecoculturally more homogenous than expected for the given level of differences in age, gender, ethnicity, or socioeconomic strata. Our long-term objectives are to initiate a larger, multi-site, research study for enhancing CPAP adherence in veterans with OSA. The ultimate goal of this research is to develop a cheap, effective and exportable system of care to promote CPAP adherence in patients with OSA.
Detailed Description
Project background: Obstructive sleep apnea (OSA) is a prevalent condition that is most frequently treated with continuous positive airway pressure (CPAP) therapy. Non-adherence to such therapy, however, afflicts a high proportion of adults with sleep apnea (46-83%). Moreover, such non-adherence to CPAP is associated with increased risk for fatal and non-fatal cardiovascular events. There remains a paucity of reliable and cost-effective interventions that could promote CPAP adherence. Promoting adherence to therapy through peer-driven intervention is cheap and has met with modest success in other chronic conditions such as HIV, heart failure and diabetes mellitus. Whether such a peer-driven ("buddy") system can improve adherence to CPAP therapy is unknown. Project Objectives: Our overall aim is to assess the feasibility and acceptability of a CPAP adherence program driven by trained "peer-buddies" with sleep apnea. Specific Objective #1: To evaluate patient ratings of the acceptability of the peer buddy system (PBS) in veterans receiving CPAP therapy for OSA. Specific Objective #2: To obtain preliminary data on the effectiveness of PBS on sleep-specific HR-QOL (Functional outcomes in sleep questionnaire [FOSQ]) in veterans receiving CPAP therapy for OSA. Specific Objective #3: To obtain preliminary data on the effect of PBS on CPAP adherence, vigilance, patient activation, and self-efficacy in veterans receiving CPAP therapy for OSA. Project Methods: In order to address these aims, we will recruit recently diagnosed patients with OSA who have not been initiated on CPAP therapy and randomly assign them to the peer-buddy system to promote adherence to CPAP therapy (intervention group) or be assigned to usual care (control group). In the PBS intervention group, trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3- month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation). The interaction will occur during supervised "in-person" sessions and during telephonic conversations over the 3-month period. Subjects from both groups will be reassessed at the end of 3 months in order to determine objective measures of CPAP adherence, sleep-specific HRQOL Functional outcomes of sleep questionnaire [FOSQ]), vigilance (psychomotor vigilance testing), measures of self-efficacy (outcome expectancy, treatment self-efficacy, and risk perception [SEMSA questionnaire]) and patient activation (Patient Activation Measure [PAM]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation).
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Peer-driven intervention
Other Intervention Name(s)
Peer-buddy system (PBS)
Intervention Description
Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation).
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
All participants will receive usual care following initiation of CPAP therapy. Visits with respiratory therapist and sleep physician wherein patients are educated about the basics of the care and operation of the device, mask and related equipment. Subsequently, their CPAP adherence is monitored and appropriate interventions such as mask change and re-education undertaken as needed.
Primary Outcome Measure Information:
Title
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time Frame
Three months
Secondary Outcome Measure Information:
Title
CPAP adherence
Time Frame
Three months
Title
Patient Activation Measure (PAM) survey assessment tool
Time Frame
Three months
Title
Self efficacy measure for sleep apnea
Time Frame
Three months
Title
Psychomotor vigilance test
Time Frame
three months
Title
Patient acceptability of peer-based intervention
Time Frame
Three months
Title
Epworth sleepiness score
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Obstructive Sleep Apnea (defined by Apnea-hypopnea index [AHI] > 5 per hour; with hypopneas defined as greater than 30% reduction in airflow with 4 or greater drop in oxygen saturation). AHI will be determined by full night or split-night polysomnography. Age range 21 - 85 years old. Stable medical history and no change in medications, including anti-hypertensive and thyroid replacement, in the previous 4 months. No regular use (> 3 times/week) of sedative or hypnotic medications in the last 4 months. Exclusion Criteria: Central sleep apnea (central apnea index > 5 per hour and >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas). Complex sleep apnea or CPAP emergent central apnea (Central apnea index > 5 per hour during CPAP titration with >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas). Requiring oxygen or bi-level positive airway pressure for treatment of OSA or hypoventilation. Decompensated cardiac (heart failure or angina) or pulmonary (severe COPD or uncontrolled asthma) disease Chronic narcotic use Nasal obstruction (nasal congestion score > 15) or enlarged tonsils Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodic limb movement disorder [ 15 limb movements/hour of sleep with arousal], central sleep apnea [ 50% of apneas on diagnostic PSG are central apneas], insomnia, obesity hypoventilation syndrome, or narcolepsy). Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other surgery for OSA. Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months. Routine consumption of more than 2 alcoholic beverages per day. Recent or recurring history of recreational drug use leading to tolerance or dependence. Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sairam Parthasarathy, MD
Organizational Affiliation
Southern Arizona VA Health Care System, Tucson, AZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Health Care System, Tucson, AZ
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21731126
Citation
Parthasarathy S. The need for pharmacovigilance in sleep medicine. Sleep. 2011 Jul 1;34(7):827-8. doi: 10.5665/SLEEP.1096. No abstract available.
Results Reference
background
PubMed Identifier
23772186
Citation
Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2013 Jun 15;9(6):543-50. doi: 10.5664/jcsm.2744.
Results Reference
derived

Learn more about this trial

A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea

We'll reach out to this number within 24 hrs