Sleep-Related Determinants of Stroke
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 15-002728
Sponsor Protocol Number: 15-002728
About this study
Stroke is the second leading cause of death worldwide. Traditional stroke risk factors explain about half of the risk for stroke. The remaining half may be partially explained by sleep duration and disturbances, which are prospectively related to incident stroke across multiple populations. Although these relationships have been identified, at present, essentially nothing is known regarding the modifiable, sleep-inhibiting behaviors that determine sleep duration and disruption; these are probable targets of stroke prevention. The study proposed here is intended to fill this void by determining the relation between sleep-inhibiting behaviors, self-reported sleep duration and disruption, and stroke amongst acute stroke inpatients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults (≥30yrs) who acutely experienced their first ischemic stroke and were hospitalized at the Mayo Clinic.
- Controls will be 40 age (±5yrs) sex, and ethnicity-matched relatives that are full/half siblings, or first cousins of the cases
- Able to understand and speak English
- Provide informed consent
Exclusion Criteria:
- Intrinsic sleep disorder diagnosis
- Screen positive for sleep apnea (STOP-BANG score of greater than three)
- Nocturnal movement-related disorder
- Decreased level of consciousness (NIH Stroke Scale (NIHSS) item 1A)
- Inability to respond correctly to questions or commands (NIHSS 1B, 1C)
- Inability to complete 3-step commands
- Cognitive dysfunction
- Aphasia
- Medical needs that would place the participant at risk or prevent the patient from receiving scheduled medical care
- Time since the event is greater than one week
- Controls will be excluded if they:
- Report a history of stroke, or stroke symptoms within the past six months
- They cannot participate within 30 days of the cases’ stroke event
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator James Parish, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available