Positive Airway Pressure Program

Sleep Apnea, Obstructive Clinical Trial

Official title:

Positive Airway Pressure Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331992
• Other study ID #: CIA-146
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: February 2018
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting around 2-4% of the middle aged population and is characterized by periodic collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal.

Over the past decade, considerable research has focused on determining the factors responsible for poor CPAP adherence. Two key areas have been identified: patient-reported symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the importance of patient education and support. In addition we know that the patient experience during the crucial first days and weeks of their journey predicts longer term adherence.

This study investigates the ability of an automated program that assists patients towards continuous positive airway pressure (CPAP) therapy adherence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18years of age

• Diagnosed with OSA (AHI >5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements

• Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years

• Own a mobile phone, and has reliable mobile network coverage at their home.

• Either: the participant will use a modem; OR the participant has access to a home internet connection (either their own, or a neighbours or friend etc) and is willing to perform a home upload.

Exclusion Criteria:

• Contraindicated for CPAP therapy

• Medically unstable condition/diagnosis that is not yet under control

• Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)

• Periodic Limb Movement Arousal Index (PLMA) greater than 15/hr during the diagnostic study

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Adherence program
Participants will receive supportive messages while enrolled in the program.

Locations

Country	Name	City	State
United States	IV Care & Respiratory	Belleville	Illinois
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Alabama Sleep Clinic	Huntsville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Providing Feedback	Participants will be provided questionnaires so as to provide program feedback.	1 month
Secondary	Healthcare Provider Feedback	Healthcare providers will be provided questionaires so as to provide program feedback.	1 month