NCT00232544

Brief Summary

This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable

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

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6 years until next milestone

Results Posted

Study results publicly available

February 17, 2014

Completed
Last Updated

October 10, 2018

Status Verified

September 1, 2018

Enrollment Period

3.4 years

First QC Date

September 30, 2005

Results QC Date

November 4, 2013

Last Update Submit

September 10, 2018

Conditions

Sleep Apnea, Obstructive

Keywords

sleep apnea, obstructiveQuality of LifeDepressionPatient Compliance

Outcome Measures

Primary Outcomes (1)

  • Objective CPAP Use

    Mean nightly hours of CPAP use over 12 months

    12 months

Secondary Outcomes (1)

  • Daytime Vigilance

    12 months

Study Arms (2)

TLC-CPAP

EXPERIMENTAL

A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)

Device: Telecommunications system

TLC-Control

PLACEBO COMPARATOR

A TLC system for providing general health education

Other: TLC-Control

Interventions

Telecommunications systemDEVICE

The telecommunications system is designed to improve patient adherence with prescribed positive airway pressure.

TLC-CPAP
TLC-ControlOTHER

A TLC system for providing general health education

TLC-Control

Eligibility Criteria

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

You may qualify if:

  • Physician diagnosis of obstructive sleep apnea syndrome plus polysomnography demonstrating greater than 10 apneas plus hypopneas per hour of sleep
  • Age 18-80 years
  • Ability to use a telephone without assistance

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.

    PMID: 20880872DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDepressionPatient Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavioral SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Results Point of Contact

Title
Dr. David Sparrow
Organization
VA Boston Healthcare System
david.sparrow@va.gov
857-364-6407

Study Officials

  • David William Sparrow, DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

October 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 10, 2018

Results First Posted

February 17, 2014

Record last verified: 2018-09

Locations

US(1)