Back to resultsContinous Positive Airway Pressure (CPAP) Compliance Study (ICAN)
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
additional educational material
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
Eligibility Criteria
Inclusion Criteria:
- Adults (age 18 - 90 years of age) newly diagnosed with OSA who have been recommended CPAP therapy.
Exclusion Criteria:
- Previously attempted CPAP, requires the use of bilevel positive airway pressure device, difficulty with English language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard of care
Additional Education
Arm Description
Participants randomized to this arm will have the usual follow up care without any additional information.
This arm will receive a weekly text message or e-mail asking participants to sign on to the web page that we will provide. Once they sign on, they will see additional educational materials and questions regarding their CPAP use. Based on their response, they will be directed to suggestion or sites to help improve their compliance with their CPAP.
Outcomes
Primary Outcome Measures
change in mean number of nursing interventions at one month
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01642160
Brief Title
Continous Positive Airway Pressure (CPAP) Compliance Study
Acronym
ICAN
Official Title
ICAN (Improvement in CPAP Adherence Via the Net) Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Does an internet based text or email interaction and education improve CPAP compliance for patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will have the usual follow up care without any additional information.
Arm Title
Additional Education
Arm Type
Active Comparator
Arm Description
This arm will receive a weekly text message or e-mail asking participants to sign on to the web page that we will provide. Once they sign on, they will see additional educational materials and questions regarding their CPAP use. Based on their response, they will be directed to suggestion or sites to help improve their compliance with their CPAP.
Intervention Type
Behavioral
Intervention Name(s)
additional educational material
Intervention Description
The internet-based intervention group would receive a weekly text or an email (based on the subject's preference). The content of the message asks about their approximate compliance over the past week. Based on their response, they will be directed to one of two internet web pages.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
participants will receive education from staff nurses as needed.
Primary Outcome Measure Information:
Title
change in mean number of nursing interventions at one month
Time Frame
baseline to one month after initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (age 18 - 90 years of age) newly diagnosed with OSA who have been recommended CPAP therapy.
Exclusion Criteria:
Previously attempted CPAP, requires the use of bilevel positive airway pressure device, difficulty with English language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Park, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Continous Positive Airway Pressure (CPAP) Compliance Study
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