CAP Pilot Study for Obstructive Sleep Apnea (OSA) | NCT02309749

Studies
CAP Pilot Study for Obstructive Sleep Apnea (OSA)

NCT02309749

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Dec 8, 2014Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 2, 2013

First Submission Date that Met QC Criteria

Dec 3, 2014

First Posted Date

Dec 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2014

Last Update Posted Date

Dec 8, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Naive cohort			Other: CAP

Name	Type	Description	Arm Group Labels	Other Names
CAP	Other		Naive cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of delivery of SMS messages to participant	Cross check recieved messages logged in a diary by the participant to those sent by CAP	30 days

Secondary Outcomes

Measure	Description	Time Frame
Participant CPAP Adherence	Assess the adherence of participants to CPAP therapy while enrolled in CAP	30 nights

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

21 to 75 years of age
Diagnosed with OSA (AHI >5 events/hour) and eligible for Continuous Positive Airway Pressure (CPAP) treatment under local requirements
Must be initiated on program (i.e. received their device) within 12 weeks of CPAP titration study
Naïve to CPAP therapy, i.e have not been prescribed CPAP in the past
Access to a cellphone

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 Leg MOvement Arousal Index greater than 15/hr
Home titration of longer than 5 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Sleep laboratory, DME supplier

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clayton Sleep Institute		St Louis	Missouri		United States
Sleep Therapy Research Center

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided