Continous Positive Airway Pressure (CPAP) Compliance Study

Obstructive Sleep Apnea (OSA) Clinical Trial

— ICAN  

Official title:

ICAN (Improvement in CPAP Adherence Via the Net) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642160
• Other study ID #: 11-008195
• Status: Completed
• Phase: N/A
• First received: July 13, 2012
• Last updated: March 5, 2013
• Start date: July 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea, Obstructive

Intervention

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.
• Standard of care
participants will receive education from staff nurses as needed.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in mean number of nursing interventions at one month		baseline to one month after initiation	No