NCT02309749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

1.4 years

First QC Date

April 2, 2013

Last Update Submit

December 4, 2014

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Participant CPAP Adherence

    30 nights

Study Arms (1)

Naive cohort

Other: CAP

Interventions

CAPOTHER
Naive cohort

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sleep laboratory, DME supplier

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clayton Sleep Institute

St Louis, Missouri, United States

Location

Sleep Therapy Research Center

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

December 5, 2014

Study Start

April 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

US(2)