Telemedici ne Management of Veterans With Newly Diagnosed Obstructiv e Sleep Apnea (OSA)

NCT02159885 | Completed

• 1 other identifier: 01473
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Automatically titrating continuous positive airway pressure (APAP) and continuous positive airway pressure (CPAP) are considered first-line treatments for obstructive sleep apnea. There is a growing body of evidence that suggests that early patient education and intervention may improve adherence with positive airway pressure. The investigators plan a prospective, randomized trial to see if telemonitoring in the first several weeks of PAP therapy improves adherence following 3 months of treatment.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; adherence; telemedicine; auto-titrating continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Average daily hours of APAP use

  Aim 1: The goal of this project is to determine whether telemedicine monitoring of APAP treatment in the first several weeks of treatment improves adherence following 3 months of treatment. Adherence will be measured objectively by the average daily hours of APAP use over 90 days.

  90 days

Secondary Outcomes (1)

• Change in FOSQ-10 score

  Change in baseline FOSQ-10 score to the FOSQ-10 score assessed at 90 days

Other Outcomes (8)

• Cost of telemonitoring (exploratory)

  90 days

• Change in ESS score

  Change in ESS score from baseline to ESS assessed at day 90 of treatment.

• Change in CES-D score

  Change in baseline CES-D and and CES-D score assessed at 90 days.

Study Arms (2)

Telemonitoring

EXPERIMENTAL

In this arm, subjects will receive usual care at the sleep clinic as well as telemonitoring of their use of their automatically adjusting continuous positive airway pressure pressure (APAP) machine. They will receiving phone calls for poor adherence and/or poor efficacy of treatment.

Other: Telemonitoring

Usual Care

NO INTERVENTION

Subjects in this arm will receive "usual care" for management of obstructive sleep apnea and use of automatically titrating continuous positive airway pressure.

Interventions

Telemonitoring OTHER

Telemonitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female veterans at least 18 years of age.
• Ability to read and speak English (assessment instruments and therapy will be available only in English).
• AHI\> 5 on baseline home sleep study
• Agree to initiate automatically titrating continuous positive airway pressure (APAP) therapy.
• Completion of clinic questionnaires during initial sleep evaluation

You may not qualify if:

• Unwilling to provide informed consent.
• Lack of English fluency. This will be determined when potential subjects are contacted by phone. If they are able to understand the oral consent by correctly completing the mini-quiz, English fluency will be established.
• No telephone access
• Patients previously treated with positive airway pressure.
• Patients enrolled in ongoing VA sleep research studies. Currently all patients enrolled in VA sleep research studies already have their charts flagged.
• Patients receiving their sleep care at VA medical centers other than PVAMC, Fort Dix, Gloucester and Victor J. Saracini (Willow Grove).
• Patients initiated on positive airway pressure treatment while in-patients will also be excluded.
• Patients who are set up with APAP machines without modems will also be excluded.

Sponsors & Collaborators

• Corporal Michael J. Crescenz VA Medical Center: lead

Study Sites (1)

Philadelphia VAMC

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Samuel Kuna, MD

  Philadelphia VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: June 10, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)