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Sleep Deficiency and Stroke Outcome

NCT02559739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 447

Last updated 2022-06-23

No results posted yet for this study

Summary

Deficient sleep duration and sleep disturbances - such as insomnia, sleep disordered breathing (SDB) and restless legs syndrome (RLS)- are associated with hypertension and cardio-cerebrovascular morbidity and mortality. Several studies suggest that sleep disorders are frequent after stroke and detrimental for stroke outcome. However, more prospective studies in a large unselected sample of stroke survivors are needed to better investigate the short- and long-term consequences of sleep disturbances on mortality and occurrence of new cardio-cerebrovascular events. Also their pathophysiological mechanisms and their influence on stroke recovery should be better understood.

Therefore, the aim of this study is to assess the impact of sleep deficiency and sleep fragmentation on the frequency of new cerebro- and cardiovascular events and death after stroke or transient ischemic attacks, and clinical outcome within one and two years after stroke.

The working hypotheses are that stroke survivors with sleep deficiency and sleep fragmentation due to insomnia, sleep-disordered breathing or restless leg syndrome will present: (1) higher mortality from all causes and higher frequency of new cardio-/ cerebrovascular events; and (2) a less favorable clinical outcome. Outcomes will be compared between patients with and without sleep deficiency and fragmentation.

Since current clinical practice in cerebrovascular patients does not sufficiently consider sleep disorders in patient's management, this study can help to bring attention to a still overlooked medical problem and change the current standard of management of stroke survivors.

Conditions

  • Sleep Apnea Syndromes
  • Sleep Initiation and Maintenance Disorders
  • Insomnia
  • Restless Legs Syndrome
  • Stroke

Sponsors & Collaborators

  • Neurocenter of Southern Switzerland

    collaborator OTHER

  • Swiss Heart Foundation

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Claudio L Bassetti, Prof. Dr. med. · Chairman and Head, Department of Neurology Inselspital, Bern University Hospital

  • Mauro Manconi, Dr. med. · Head of Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Lugano

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-05-05
Completion
2022-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02559739 on ClinicalTrials.gov