Remote Monitoring in Obstructive Sleep Apnea

NCT01678560 | Terminated Results

• 1 other identifier: 01648
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to the patient in terms of serious co-morbidities and results in a great cost to the VA Health Care System to treat the co-morbidities, which include heart disease, stroke and neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and studies have shown a poor adherence to treatment. The investigators hypothesize that using wireless technology will lead to early detection of problems of treatment use and will translate into early remedial action which will improve the use and effectiveness of treatment. The investigators will compare two methods. Usual care involves downloading data from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit. Wireless care involved more frequent monitoring and intervention in the event of anomalies in treatment use or effectiveness.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea PAP adherence efficacy economics

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months

  Positive Airway Pressure Treatment Adherence defined as mean PAP use being \> 4 hours per night for greater than 70% of nights.

  First 3 months

• Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months

  Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being \> 4 hours per night for greater than 70% of nights

  4-12 Months

Secondary Outcomes (1)

• Receiving Effective Treatment for Obstructive Sleep Apnea

  12 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Monitoring every 3 months by face-to-face visits:These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.

Device: Monitoring every 3 months by face-to-face visits

Wireless Care

ACTIVE COMPARATOR

Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.

Device: Frequent remote monitoring

Interventions

Monitoring every 3 months by face-to-face visits DEVICE

These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.

Usual Care

Frequent remote monitoring DEVICE

These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls

Wireless Care

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed OSA patients
• AHI of 5/hour or greater
• Prescribed CPAP therapy
• Able to comply with treatment and understand treatment instructions

You may not qualify if:

• Not able to understand study requirements
• Significant cardiorespiratory disease - e.g. COPD (chronic obstructive pulmonary disease), severe CHF (congestive heart failure)
• Clinical instability at time of apnea diagnosis
• Prescribed BiPap (bilevel positive airway pressure) or ASV (Adaptive Support Ventilation), which are other types of PAP

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead

Study Sites (1)

VA Connecticut Health System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

• Naik S, Al-Halawani M, Kreinin I, Kryger M. Centers for Medicare and Medicaid Services Positive Airway Pressure Adherence Criteria May Limit Treatment to Many Medicare Beneficiaries. J Clin Sleep Med. 2019 Feb 15;15(2):245-251. doi: 10.5664/jcsm.7626.

  PMID: 30736874 DERIVED

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

Limitations and Caveats

CPAP was outsourced eliminating the point of recruitment which halted limiting the study proceeded to the follow-up of recruited patients. Planned statistical data analysis was not performed due to the smaller then expected numbers (expected 220)

Results Point of Contact

• Title: Meir Kryger, MD
• Organization: Yale University

meir.kryger@yale.edu

203-815-0914

Study Officials

• Meir Kryger, MD

  VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 5, 2012
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 11, 2019
• Results First Posted: December 11, 2019

Record last verified: 2019-12

Locations

US (1)