NCT00662623

Brief Summary

The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

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, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

April 16, 2008

Last Update Submit

May 12, 2016

Conditions

Keywords

Chronic Obstructive Sleep ApneaSleep ApneaSleep Apnea Treatment

Outcome Measures

Primary Outcomes (1)

  • CPAP Adherence

    4 months

Secondary Outcomes (1)

  • Quality of patient-centered collaborative care

    4 months

Study Arms (2)

1

EXPERIMENTAL
Behavioral: i-PAP

2

ACTIVE COMPARATOR

Usual Care (Standard Care)

Behavioral: Usual Care (Standard Care)

Interventions

i-PAPBEHAVIORAL

Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care

1

Pre-determined clinic visits and telephone support

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • confirmed diagnosis of OSA
  • being newly prescribed CPAP therapy
  • having chronic symptoms as noted on screening symptom checklist
  • fluency in English

You may not qualify if:

  • cognitive impairment sufficient to cause inability to complete the protocol (MMSE \< 24/30)
  • residence in a geographical area outside of San Diego County
  • fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
  • significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Medical Research Foundation

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Carl J. Stepnowsky, PhD

    Veterans Medical Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study PI

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations