Telemedicine Monitoring of Sleep Apnea in Stroke

NCT02748681 | Completed

• 1 other identifier: HOPESV3
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives: Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in stroke patients, with adherence rates for CPAP therapy of only 30%. The primary objective of this study is to determine whether CPAP adherence in stroke patients with obstructive sleep apnea can be improved by a CPAP training strategy during rehabilitation combined with a telemedicine monitoring system after discharge. The secondary objective is to compare recording quality as well as subjective and objective sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in the management of sleep apnea in stroke. Further the investigators aim to study changes in nocturnal systolic blood pressure due to CPAP therapy with the pulse transit time method. Finally, the investigators intend to study the relationship between CPAP compliance, sleep and medical and neurorehabilition outcome parameters. Design: Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to severe OSA. Setting: Neurorehabilitation center in Vienna, Austria Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal AHI\< 10) at the neurorehabilitation unit. Interventions: Patients will be randomized to either standard care with an autotitrating CPAP device or an autotitrating CPAP device that transmits physiologic information (i.e., adherence, air leak, residual AHI) daily to a website that will be reviewed by their homecare provider. If any problems are identified, the patient will be contacted by his homecare provider by telephone. Neurologists performing sleep and neurological scoring will be blinded to the randomization. Measurements: Recording of the different measuring systems, subjective and objective sleep quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP determined by means of a non-linear algorithm and an individual one-point calibration of the pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH, Germany) and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.

Conditions

Stroke; Sleep Apnea

Keywords

obstructive sleep apnea; CPAP; stroke; telemedicine; neurorehabilitation; systolic blood pressure

Outcome Measures

Primary Outcomes (1)

• CPAP adherence in minutes used per night

  after 3 months

Secondary Outcomes (1)

• systolic BP

  Change from baseline systolic blood pressure to CPAP systolic blood pressure at three months

Other Outcomes (1)

• Barthel Index

  Change from baseline score to score under CPAP therapy at three months

Study Arms (2)

Telemedicine Group

ACTIVE COMPARATOR

Patient group with a telemedicine monitoring system

Device: Auto CPAP AirSense™ 10(Resmed)

Standard Group

ACTIVE COMPARATOR

Patient Group without a telemedicine monitoring

Device: Auto CPAP AirSense™ 10(Resmed)

Interventions

Auto CPAP AirSense™ 10(Resmed) DEVICE

AutoSet CPAP without telemedicine monitoring

Standard Group; Telemedicine Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-70 yrs of age) with a subacute stroke (1-12 months)
• Diagnosis of sleep apnea and acceptance of CPAP therapy:

You may not qualify if:

• Patients with sopor/coma
• Any form of dementia (Mini-Mental State Examination \<20)
• Previously diagnosed sleep apnea and established CPAP therapy
• Purely central sleep apnea
• Chronic obstructive pulmonary disease more than Gold III
• Cancer
• Severe kidney diseases
• Coexisting causes of daytime sleepiness (e.g. narcolepsy, night or rotating shift-work; self-reported average sleep duration \<4 h)
• A major psychiatric or any other acute medical condition
• Patients unable or unwilling to comply with the protocol

Sponsors & Collaborators

• Neurologisches Rehabiliationszentrum Rosenhügel: lead

Study Sites (1)

Michael Saletu, MD

Vienna, 1130, Austria

Location

Related Publications (3)

• Kotzian ST, Saletu MT, Schwarzinger A, Haider S, Spatt J, Kranz G, Saletu B. Proactive telemedicine monitoring of sleep apnea treatment improves adherence in people with stroke- a randomized controlled trial (HOPES study). Sleep Med. 2019 Dec;64:48-55. doi: 10.1016/j.sleep.2019.06.004. Epub 2019 Jun 13.

  PMID: 31670004 DERIVED

• Saletu MT, Kotzian ST, Schwarzinger A, Haider S, Spatt J, Saletu B. Home Sleep Apnea Testing is a Feasible and Accurate Method to Diagnose Obstructive Sleep Apnea in Stroke Patients During In-Hospital Rehabilitation. J Clin Sleep Med. 2018 Sep 15;14(9):1495-1501. doi: 10.5664/jcsm.7322.

  PMID: 30176970 DERIVED

• Kotzian ST, Schwarzinger A, Haider S, Saletu B, Spatt J, Saletu MT. Home polygraphic recording with telemedicine monitoring for diagnosis and treatment of sleep apnoea in stroke (HOPES Study): study protocol for a single-blind, randomised controlled trial. BMJ Open. 2018 Jan 9;8(1):e018847. doi: 10.1136/bmjopen-2017-018847.

  PMID: 29317418 DERIVED

MeSH Terms

Conditions

Stroke; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Michael T Saletu, MD

  Neurological Rehabilitation Center Rosenhügel Rosenhügelstrasse 192a, A-1130

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 22, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

AU (1)