NCT00945776

Brief Summary

The purpose of this study is to compare the effects of three interventions on CPAP adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

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
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Last Updated

July 24, 2009

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

July 23, 2009

Last Update Submit

July 23, 2009

Conditions

Keywords

OSACPAP

Outcome Measures

Primary Outcomes (1)

  • To determine which intervention will improve CPAP compliance in sleep apnea

    6 weeks

Secondary Outcomes (1)

  • To try to identify which individual characteristics within a group may require a specific intervention

    6 weeks

Study Arms (3)

Weekly phone calls

ACTIVE COMPARATOR

Will be called weekly to answer questions regarding usage.

Behavioral: Weekly phone calls

Frequently asked questions

ACTIVE COMPARATOR

Providing written general answers to commonly asked questions.

Behavioral: Frequently asked questions

Usual care

ACTIVE COMPARATOR
Behavioral: Usual care

Interventions

Calling weekly to answer questions regarding CPAP usage.

Weekly phone calls

Answers to frequently asked questions in pre-printed form.

Frequently asked questions
Usual careBEHAVIORAL

Answers will be provided by the renter of the equipment, and the sleep center if asked in addition to explanations by the sleep specialist.

Usual care

Eligibility Criteria

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

You may qualify if:

  • All new patients undergoing of the Sleep Center suspected of having sleep apnea and undergoing sleep studies

You may not qualify if:

  • Refusal to participate, or not suspected of having sleep apnea prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMC Sleep Center

Charleston, West Virginia, 25301, 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 Officials

  • George L Zaldivar, M.D.

    CAMC Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

April 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 24, 2009

Record last verified: 2009-07

Locations