Sleep Deficiency and Stroke Outcome

NCT02559739 | Completed

• 2 other identifiers: 014/15320030_149752
• Study Type: observational
• Target: 447
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Stroke; Ischemic Attack, Transient; Cardiovascular Diseases; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Insomnia; Restless Legs Syndrome; Sleep Deprivation

Outcome Measures

Primary Outcomes (1)

• A composite of death from any cause, stroke, transient ischemic attack, myocardial infarction, unplanned hospitalization (or unplanned prolongation of hospitalization) for heart failure or leading to urgent revascularization within 24 months

  24 months after stroke

Secondary Outcomes (14)

• Clinical outcome after stroke, as assessed by modified Rankin scale

  12 months after stroke

• Clinical outcome after stroke, as assessed by Barthel index

  12 months after stroke

• Clinical outcome after stroke, as assessed by Quality of Life Questionnaire

  12 months after stroke

• A composite of death from any cause, stroke, transient ischemic attack, myocardial infarction, unplanned hospitalization (or unplanned prolongation of hospitalization) for heart failure or leading to urgent revascularization)

  3 and 12 months and 2 to 4 years after stroke

• Frequency of new-onset sleep deficiency

  3, 12 and 24 months after stroke

Study Arms (2)

Sleep deficiency/fragmentation

Patients with sleep deficiency/fragmentation

No sleep deficiency/fragmentation

Patients without sleep deficiency/fragmentation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from ischemic stroke or transient ischemic attack (TIA) will be recruited at the Stroke Unit and the ward of the Department of Neurology, Inselspital Bern, and the Stroke Unit and ward of the Neurocenter of Southern Switzerland, Lugano, and followed-up for (at least) 2 (maximum 4) years. They will be evaluated for pre-existing and new-onset sleep disturbances that result in sleep deficiency (\< 6h sleep /night and/or post-stroke reduction of average sleep time/night ≥ 2h) or sleep fragmentation (insomnia, sleep-disordered breathing, restless legs syndrome).

You may qualify if:

• Patients' informed consent as documented by signature.
• Hospitalization either at the Stroke Unit and ward of the Department of Neurology, Inselspital Bern or at the Stroke Unit and ward of the Neurocenter of Southern Switzerland (Lugano)
• Age: 18-85
• Transient ischemic attack or ischemic stroke of any localization
• Written informed consent

You may not qualify if:

• Primary hemorrhagic stroke
• Coma/Stupor
• Clinical unstable or life threatening condition (severe heart failure, oxygen-dependent pulmonary disease or severe pulmonary complications, severe renal or liver insufficiency)
• Pregnancy
• Drug or alcohol abuse
• Inability of the participant to give informed consent (e.g. patients under tutelage) or to follow the procedures of the study due to psychological or medical conditions

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Neurocenter of Southern Switzerland: collaborator
• Swiss Heart Foundation: collaborator

Study Sites (2)

Department of Neurology Inselspital, Bern University Hospital

Bern, Canton Bern, 3010, Switzerland

Location

Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Civic Hospital of Lugano

Lugano, 6900, Switzerland

Location

Related Publications (7)

• Hodor A, Palchykova S, Gao B, Bassetti CL. Baclofen and gamma-hydroxybutyrate differentially altered behavior, EEG activity and sleep in rats. Neuroscience. 2015 Jan 22;284:18-28. doi: 10.1016/j.neuroscience.2014.08.061. Epub 2014 Oct 6.

  PMID: 25301745 BACKGROUND

• Poryazova R, Huber R, Khatami R, Werth E, Brugger P, Barath K, Baumann CR, Bassetti CL. Topographic sleep EEG changes in the acute and chronic stage of hemispheric stroke. J Sleep Res. 2015 Feb;24(1):54-65. doi: 10.1111/jsr.12208. Epub 2014 Aug 27.

  PMID: 25159577 BACKGROUND

• Cereda CW, Petrini L, Azzola A, Ciccone A, Fischer U, Gallino A, Gyorik S, Gugger M, Mattis J, Lavie L, Limoni C, Nobili L, Manconi M, Ott S, Pons M, Bassetti CL. Sleep-disordered breathing in acute ischemic stroke and transient ischemic attack: effects on short- and long-term outcome and efficacy of treatment with continuous positive airways pressure--rationale and design of the SAS CARE study. Int J Stroke. 2012 Oct;7(7):597-603. doi: 10.1111/j.1747-4949.2012.00836.x. Epub 2012 Jul 19.

  PMID: 22812731 BACKGROUND

• Siccoli MM, Valko PO, Hermann DM, Bassetti CL. Central periodic breathing during sleep in 74 patients with acute ischemic stroke - neurogenic and cardiogenic factors. J Neurol. 2008 Nov;255(11):1687-92. doi: 10.1007/s00415-008-0981-9. Epub 2008 Nov 13.

  PMID: 19009334 BACKGROUND

• Hermann DM, Siccoli M, Kirov P, Gugger M, Bassetti CL. Central periodic breathing during sleep in acute ischemic stroke. Stroke. 2007 Mar;38(3):1082-4. doi: 10.1161/01.STR.0000258105.58221.9a. Epub 2007 Jan 25.

  PMID: 17255543 BACKGROUND

• Yang X, Lippert J, Dekkers M, Baillieul S, Duss SB, Reichlin T, Brill AK, Bernasconi C, Schmidt MH, Bassetti CLA. Impact of Comorbid Sleep-Disordered Breathing and Atrial Fibrillation on the Long-Term Outcome After Ischemic Stroke. Stroke. 2024 Mar;55(3):586-594. doi: 10.1161/STROKEAHA.123.042856. Epub 2024 Jan 26.

  PMID: 38275115 DERIVED

• Filchenko I, Murner N, Dekkers MPJ, Baillieul S, Duss SB, Brill AK, Horvath T, Heldner MR, Rexhaj E, Bernasconi C, Bassetti CLA, Schmidt MH. Blood pressure variability, nocturnal heart rate variability and endothelial function predict recurrent cerebro-cardiovascular events following ischemic stroke. Front Cardiovasc Med. 2023 Nov 16;10:1288109. doi: 10.3389/fcvm.2023.1288109. eCollection 2023.

  PMID: 38034378 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Restless Legs Syndrome; Stroke; Ischemic Attack, Transient; Cardiovascular Diseases; Sleep Deprivation

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parasomnias; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Brain Ischemia; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudio L Bassetti, Prof. Dr. med.

  Chairman and Head, Department of Neurology Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Mauro Manconi, Dr. med.

  Head of Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Lugano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 24, 2015
• Study Start: July 1, 2015
• Primary Completion: May 5, 2021
• Study Completion: March 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

CH (2)