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Positive Airway Pressure Program

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ClinicalTrials.gov Identifier: NCT02331992
Recruitment Status : Completed
First Posted : January 6, 2015
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Behavioral: Adherence program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Positive Airway Pressure Program
Study Start Date : February 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Positive airway pressure adherence program
Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.
 Behavioral: Adherence program
Participants will receive supportive messages while enrolled in the program.


Outcome Measures
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Primary Outcome Measures :
  1. Participant Providing Feedback [ Time Frame: 1 month ]
    Participants will be provided questionnaires so as to provide program feedback.


Secondary Outcome Measures :
  1. Healthcare Provider Feedback [ Time Frame: 1 month ]
    Healthcare providers will be provided questionaires so as to provide program feedback.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331992


Locations
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United States, Alabama
Alabama Sleep Clinic
Huntsville, Alabama, United States, 35801
United States, Illinois
IV Care & Respiratory
Belleville, Illinois, United States, 62223
United States, South Carolina
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
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Study Chair: Hamish Collie, MHlthSc Fisher & Paykel Healthcare
More Information
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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02331992    
Other Study ID Numbers: CIA-146
First Posted: January 6, 2015    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: February 2018
Keywords provided by Fisher and Paykel Healthcare:
Continuous Positive Airway Pressure
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases