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Continous Positive Airway Pressure (CPAP) Compliance Study (ICAN)

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642160

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John Park, MD Mayo Clinic
  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, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014