NCT01259440

Brief Summary

Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

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

First Submitted

Initial submission to the registry

December 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 4, 2015

Completed
Last Updated

November 4, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

December 10, 2010

Results QC Date

February 20, 2015

Last Update Submit

October 5, 2015

Conditions

Keywords

Telemedicinecontinuous positive airway pressuretreatment adherence

Outcome Measures

Primary Outcomes (1)

  • Treatment Adherence

    Nightly CPAP adherence measured over the two-month period .

    2 months

Study Arms (2)

Video Teleconferencing Care

ACTIVE COMPARATOR

Video teleconferencing care

Behavioral: Video Teleconferencing Care

Usual Care

PLACEBO COMPARATOR

Usual Care

Behavioral: Usual Care

Interventions

The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.

Video Teleconferencing Care
Usual CareBEHAVIORAL

Consists of one week telephone call and one month clinic visit

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Moderate to Severe Sleep Apnea
  • Live in San Diego County
  • Veteran

You may not qualify if:

  • Previous use of positive pressure airway therapy
  • Residence outside of San Diego county

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHealth BehaviorBehavior

Results Point of Contact

Title
Carl J. Stepnowsky, PhD
Organization
VA San Diego Healthcare System

Study Officials

  • Carl J Stepnowsky, PhD

    San Diego Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 14, 2010

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

November 4, 2015

Results First Posted

November 4, 2015

Record last verified: 2015-10

Locations