Sleep Apnea SyndromesNCT02559739
Sleep Deficiency and Stroke Outcome
An observational study of Sleep Apnea Syndromes and Sleep Initiation and Maintenance Disorders, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Insomnia
- How many people
- 447 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jul 2015to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
- Symptom onset until study inclusion ≤ 7 days
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Neurology Inselspital, Bern University Hospital
Bern, Canton Bern, 3010
Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Civic Hospital of Lugano
Lugano, 6900
About this study
Official title: Sleep Deficiency and Sleep Fragmentation and Their Impact on the Short- and Long-term Outcome of Ischemic Stroke and Transient Ischemic Attacks - a Two-center Prospective Observational Cohort Study
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.
Read more
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.
Read the detailed description
Background
Experimental and clinical data suggest a detrimental effect of sleep deficiency/sleep fragmentation on stroke outcome. In rodents, sleep fragmentation and sleep deprivation induced in the acute phase of stroke enhance the extension of the lesion and impair functional recovery - inversely, sleep-promoting drugs have a positive effect on functional recovery. In humans, a negative effect of sleep deficiency and sleep fragmentation due to sleep-disordered breathing (SDB), restless legs syndrome (RLS) and insomnia on stroke outcome has also been suggested but only insufficiently tested.
SDB is found in 50-70% of patients with transient ischemic attacks and acute ischemic stroke. Patients with SDB demonstrate a more rapid progression of stroke severity as well as higher blood pressure and longer hospitalization in the acute phase of stroke. Over time, they also exhibit a higher mortality. Functional outcome is also negatively affected by the presence of SDB. Moreover, SDB was shown to represent an independent risk for hypertension and cardiovascular morbidity and mortality, and for stroke.
The frequency of insomnia in patients with stroke in a prospective study achieved 68% in the acute phase decreasing to 49% after 18 months. However, systematic large scale observational studies on the frequency of insomnia in stroke patients are lacking. Sleep duration after stroke has been assessed in few studies only (e.g. in patients with paramedian thalamic stroke), in some of them a good correlation with actigraphic measurements was found. Moreover, over the last three decades a link was found between sleep deficiency and fragmentation and cardiocerebrovascular morbidity and mortality based on epidemiological data. In particular, short sleepers (e.g. sleep duration < 6 hours) and poor sleepers (reporting a non-restorative sleep) presented a higher risk of cardiovascular events including death, coronary heart disease and stroke. Insomnia and sleep duration in the general population were also reported to predispose to an increased risk of hypertension, cardiovascular events and mortality.
A high association between RLS and stroke was demonstrated in a few studies. RLS was found in 12% of 137 patients after stroke and predicted a worse outcome. Few case reports reported high numbers of periodic limb movements during sleep (PLMS), which are often associated with RLS, in stroke patients. An association of RLS/PLMS with hypertension, cardiovascular diseases and stroke was also discussed in recent years. However, the large scale data on the impact of RLS for the stroke outcomes are lacking.
The possible mechanisms linking sleep deficiency, poor sleep and sleep fragmentation with cardiovascular disorders (including stroke) are multiple and include an elevated sympathetic activation, procoagulatory and inflammatory changes, increased atherosclerosis, and changes in cerebral hemodynamics and oxygenation. However, the clinical relevance and the association with clinical outcomes needs further investigation.
Objective
The aim of this study is to assess the impact of sleep deficiency and sleep fragmentation resulting from insomnia, SDB or RLS on the frequency of new cerebro- and cardiovascular events after stroke or TIA including death of any cause, and clinical outcome within one and two years after stroke.
Primary objective of the study is the assessment of the frequency of all-cause deaths and new cerebro- and cardiovascular events within 24 months after stroke or transient ischemic attack in patients with and without sleep deficiency/fragmentation.
The main secondary objective is an assessment of clinical outcome 12 months after stroke in patients with and without sleep deficiency/fragmentation.
Methods
Patients with acute ischemic stroke or TIA will be recruited at two Neurology Departments in Switzerland (Inselspital Bern \& Neurocenter of Southern Switzerland Lugano). Two groups will be formed based on the presence or absence of sleep deficiency/fragmentation assessed at one month following stroke by questionnaires and telephone interviews. Examinations (at baseline \& 3, 12 and 24 months follow up after stroke) will include standardized and validated questionnaires assessing stroke outcome (independence and activities of daily living) as well as insomnia, RLS, risk for sleep apnea, depression and apathy. Additional non-invasive physiological assessments will be performed in about every fifth of all recruited patients in the acute phase of stroke and after 3 and 12 months. They include ambulatory blood pressure measurements and wrist activity assessing 24h physical activity patterns over 3 weeks, assessment of arterial stiffness/endothelial function and basic cognitive performance.
- 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
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Restless Legs Syndrome, Stroke, Ischemic Attack, Transient, Cardiovascular Diseases, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep deficiency/fragmentation | Patients with sleep deficiency/fragmentation | |
| No sleep deficiency/fragmentation | Patients without sleep deficiency/fragmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months after stroke
Secondary outcomes (14)
Clinical outcome after stroke, as assessed by modified Rankin scale
Measured: 12 months after stroke
Clinical outcome after stroke, as assessed by Barthel index
Measured: 12 months after stroke
Clinical outcome after stroke, as assessed by Quality of Life Questionnaire
Measured: 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)
Measured: 3 and 12 months and 2 to 4 years after stroke
Frequency of new-onset sleep deficiency
Measured: 3, 12 and 24 months after stroke
Frequency of insomnia
Measured: 3, 12 and 24 months after stroke
Frequency of RLS
Measured: 3, 12 and 24 months after stroke
Risk for sleep-disordered breathing
Measured: 3, 12 and 24 months after stroke
Arterial stiffness (assessed in 1/5 of all patients)
Measured: Baseline, 3 and 12 months after stroke
Endothelial function (assessed in 1/5 of all patients)
Measured: Baseline, 3 and 12 months after stroke
Blood pressure values (variability and absolute values, assessed in 1/5 of all patients 3 times a day over 3 weeks)
Measured: Baseline, 3 and 12 months after stroke
3-week wrist-actigraphy parameters (including inactivity and activity indices) (assessed in 1/5 of all patients)
Measured: Baseline, 3 and 12 months after stroke
Basic cognitive performance (Montreal Cognitive Assessment) (assessed in 1/5 of all patients)
Measured: Baseline, 3 and 12 months after stroke
Course of SDB frequency measured by an objective respirography (assessed in 1/5 of all patients)
Measured: Baseline, 3 and 12 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion5 May 2021
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Neurocenter of Southern Switzerland, Swiss Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Claudio L Bassetti, Prof. Dr. med., Principal investigator, Chairman and Head, Department of Neurology Inselspital, Bern University HospitalMauro Manconi, Dr. med., Principal investigator, Head of Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559739
- Sponsor's protocol ID
- 014/15
- Other IDs
- 320030_149752
- Status last verified
- Jun 2022
- First submitted
- 21 Sep 2015
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25301745Poryazova 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.
PubMed 25159577Cereda 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.
PubMed 22812731Siccoli 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.
PubMed 19009334Hermann 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.
PubMed 17255543Yang 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.
PubMed 38275115Filchenko 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.
PubMed 38034378
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Deficiency and Sleep Fragmentation and Their Impact on the Short- and Long-term Outcome of Ischemic Stroke and Transient Ischemic Attacks - a Two-center Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02559739
- Acronym / sponsor ID
- 014/15
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Neurocenter of Southern Switzerland, Swiss Heart Foundation
- Study start
- Jul 2015 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Experimental and clinical data suggest a detrimental effect of sleep deficiency/sleep fragmentation on stroke outcome. In rodents, sleep fragmentation and sleep deprivation induced in the acute phase of stroke enhance the extension of the lesion and impair functional recovery - inversely, sleep-promoting drugs have a positive effect on functional recovery. In humans, a negative effect of sleep deficiency and sleep fragmentation due to sleep-disordered breathing (SDB), restless legs syndrome (RLS) and insomnia on stroke outcome has also been suggested but only insufficiently tested.
SDB is found in 50-70% of patients with transient ischemic attacks and acute ischemic stroke. Patients with SDB demonstrate a more rapid progression of stroke severity as well as higher blood pressure and longer hospitalization in the acute phase of stroke. Over time, they also exhibit a higher mortality. Functional outcome is also negatively affected by the presence of SDB. Moreover, SDB was shown to represent an independent risk for hypertension and cardiovascular morbidity and mortality, and for stroke.
The frequency of insomnia in patients with stroke in a prospective study achieved 68% in the acute phase decreasing to 49% after 18 months. However, systematic large scale observational studies on the frequency of insomnia in stroke patients are lacking. Sleep duration after stroke has been assessed in few studies only (e.g. in patients with paramedian thalamic stroke), in some of them a good correlation with actigraphic measurements was found. Moreover, over the last three decades a link was found between sleep deficiency and fragmentation and cardiocerebrovascular morbidity and mortality based on epidemiological data. In particular, short sleepers (e.g. sleep duration < 6 hours) and poor sleepers (reporting a non-restorative sleep) presented a higher risk of cardiovascular events including death, coronary heart disease and stroke. Insomnia and sleep duration in the general population were also reported to predispose to an increased risk of hypertension, cardiovascular events and mortality.
A high association between RLS and stroke was demonstrated in a few studies. RLS was found in 12% of 137 patients after stroke and predicted a worse outcome. Few case reports reported high numbers of periodic limb movements during sleep (PLMS), which are often associated with RLS, in stroke patients. An association of RLS/PLMS with hypertension, cardiovascular diseases and stroke was also discussed in recent years. However, the large scale data on the impact of RLS for the stroke outcomes are lacking.
The possible mechanisms linking sleep deficiency, poor sleep and sleep fragmentation with cardiovascular disorders (including stroke) are multiple and include an elevated sympathetic activation, procoagulatory and inflammatory changes, increased atherosclerosis, and changes in cerebral hemodynamics and oxygenation. However, the clinical relevance and the association with clinical outcomes needs further investigation.
Objective
The aim of this study is to assess the impact of sleep deficiency and sleep fragmentation resulting from insomnia, SDB or RLS on the frequency of new cerebro- and cardiovascular events after stroke or TIA including death of any cause, and clinical outcome within one and two years after stroke.
Primary objective of the study is the assessment of the frequency of all-cause deaths and new cerebro- and cardiovascular events within 24 months after stroke or transient ischemic attack in patients with and without sleep deficiency/fragmentation.
The main secondary objective is an assessment of clinical outcome 12 months after stroke in patients with and without sleep deficiency/fragmentation.
Methods
Patients with acute ischemic stroke or TIA will be recruited at two Neurology Departments in Switzerland (Inselspital Bern \& Neurocenter of Southern Switzerland Lugano). Two groups will be formed based on the presence or absence of sleep deficiency/fragmentation assessed at one month following stroke by questionnaires and telephone interviews. Examinations (at baseline \& 3, 12 and 24 months follow up after stroke) will include standardized and validated questionnaires assessing stroke outcome (independence and activities of daily living) as well as insomnia, RLS, risk for sleep apnea, depression and apathy. Additional non-invasive physiological assessments will be performed in about every fifth of all recruited patients in the acute phase of stroke and after 3 and 12 months. They include ambulatory blood pressure measurements and wrist activity assessing 24h physical activity patterns over 3 weeks, assessment of arterial stiffness/endothelial function and basic cognitive performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deficiency/fragmentation | – | –Patients with sleep deficiency/fragmentation |
| No sleep deficiency/fragmentation | – | –Patients without sleep deficiency/fragmentation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
- Symptom onset until study inclusion ≤ 7 days
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 24 months after stroke
14 secondary outcomes
Clinical outcome after stroke, as assessed by modified Rankin scale
Time frame: 12 months after stroke
Clinical outcome after stroke, as assessed by Barthel index
Time frame: 12 months after stroke
Clinical outcome after stroke, as assessed by Quality of Life Questionnaire
Time frame: 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)
Time frame: 3 and 12 months and 2 to 4 years after stroke
Frequency of new-onset sleep deficiency
Time frame: 3, 12 and 24 months after stroke
Frequency of insomnia
Time frame: 3, 12 and 24 months after stroke
Frequency of RLS
Time frame: 3, 12 and 24 months after stroke
Risk for sleep-disordered breathing
Time frame: 3, 12 and 24 months after stroke
Arterial stiffness (assessed in 1/5 of all patients)
Time frame: Baseline, 3 and 12 months after stroke
Endothelial function (assessed in 1/5 of all patients)
Time frame: Baseline, 3 and 12 months after stroke
Blood pressure values (variability and absolute values, assessed in 1/5 of all patients 3 times a day over 3 weeks)
Time frame: Baseline, 3 and 12 months after stroke
3-week wrist-actigraphy parameters (including inactivity and activity indices) (assessed in 1/5 of all patients)
Time frame: Baseline, 3 and 12 months after stroke
Basic cognitive performance (Montreal Cognitive Assessment) (assessed in 1/5 of all patients)
Time frame: Baseline, 3 and 12 months after stroke
Course of SDB frequency measured by an objective respirography (assessed in 1/5 of all patients)
Time frame: Baseline, 3 and 12 months after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Background: PubMed 25301745Hodor 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.
- Background: PubMed 25159577Poryazova 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.
- Background: PubMed 22812731Cereda 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.
- Background: PubMed 19009334Siccoli 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.
- Background: PubMed 17255543Hermann 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.
- Derived from this study: PubMed 38275115Yang 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.
- Derived from this study: PubMed 38034378Filchenko 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.
Related trials for Sleep Apnea Syndromes
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio L Bassetti, Prof. Dr. med. principal investigator
Chairman and Head, Department of Neurology Inselspital, Bern University Hospital
Mauro Manconi, Dr. med. principal investigator
Head of Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Lugano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes and Sleep Initiation and Maintenance Disorders, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 24 months after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559739, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.