Continous Positive Airway Pressure (CPAP) Compliance Study (ICAN)
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
John G. Park, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01642160
First received: July 13, 2012
Last updated: March 5, 2013
Last verified: March 2013
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Purpose
Does an internet based text or email interaction and education improve CPAP compliance for patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea (OSA) |
Behavioral: additional educational material Behavioral: Standard of care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ICAN (Improvement in CPAP Adherence Via the Net) Study |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- change in mean number of nursing interventions at one month [ Time Frame: baseline to one month after initiation ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | July 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard of care
Participants randomized to this arm will have the usual follow up care without any additional information.
|
Behavioral: Standard of care
participants will receive education from staff nurses as needed.
|
|
Active Comparator: Additional Education
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.
|
Behavioral: additional educational material
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | John G. Park, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01642160 History of Changes |
| Other Study ID Numbers: | 11-008195 |
| Study First Received: | July 13, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013