NCT07885826Toborzás még nem indult
Prospective Longitudinal Study of Sleep, Brain Activity, and Plasma Analyses in Patients Undergoing Epilepsy Surgery
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 21.
Rövid összefoglaló (regiszter, angolul)
The goal of this observational study is to understand how sleep and brain activity change after epilepsy surgery in adults with drug-resistant epilepsy. Drug-resistant epilepsy means that seizures continue despite treatment with appropriate medications. The study will investigate whether changes in sleep and brain activity are related to seizure control, sleep quality, and quality of life after surgery. The main questions it aims to answer are: * How do sleep patterns and brain activity change after epilepsy surgery? * How are changes in sleep and brain activity related to seizure control and quality of life? * Do sleep patterns after surgery become more like those of healthy adults? * How are changes in blood proteins related to sleep, brain activity, and seizure control? Researchers will follow 30 adults undergoing epilepsy surgery. Their sleep will be compared with that of 10 healthy adults of similar age and sex. Healthy participants will complete the study assessments once. Participants undergoing epilepsy surgery will complete the assessments before surgery and approximately 2 and 6 months after surgery. At each assessment, participants will: * Wear a small device (actigraph) on their wrist for about 2 weeks to measure sleep and activity and keep a sleep diary. * Spend 2 consecutive nights at a patient hotel while their sleep and brain activity are recorded using polysomnography (PSG), a test that measures sleep, breathing, and brain activity. * Answer questionnaires about sleep quality, insomnia, mood, and quality of life. * Provide blood samples for research. Researchers will also collect information about seizure frequency, medications, and medical history. The sleep recordings will be used to study several aspects of sleep, including: * Sleep architecture: how much time participants spend in different stages of sleep and how often their sleep is interrupted. * Sleep spindles and slow oscillations: patterns of brain activity during sleep that are involved in how the brain processes and organizes information. * Cyclic alternating pattern (CAP): a measure of brief changes in brain activity during sleep that can provide information about sleep stability. * Epileptiform activity: abnormal electrical activity in the brain that may be associated with epilepsy and can occur during sleep. Researchers will also analyze proteins in blood samples to explore whether biological changes are related to sleep and seizure outcomes. Epilepsy surgery and other medical treatments will be decided by the participants' treating healthcare teams, independently of this study. The study will observe changes before and after surgery without assigning participants to a treatment.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2026. okt. 6.
- Kezdés
- 2026. szept. 21.
- Elsődleges befejezés
- 2029. dec. 1.
- Fő szponzor
- Region Skane
- Betegségek
- Epilepszia
- NCT-szám
- NCT07885826
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 40
- 2026. szept. 21. és az elsődleges befejezés (2029. dec. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- Inability to complete the study assessments, for example due to cognitive impairment or another medical condition.
Egyéb
- Inability to provide informed consent.
Kiket keres a vizsgálat
- Adults aged ≥18 years who have been offered and accepted epilepsy surgery following a clinical decision at the epilepsy surgery conference at Skåne University Hospital.
- Ability to provide informed consent.
- Healthy controls: age- and sex-matched adults without a diagnosis of epilepsy or a diagnosed sleep disorder, and able to provide informed consent.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Skåne University Hospital | Lund | Svédország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.