Status:
COMPLETED
EEG Changes of type1 Diabetes During Sleep -Insulin Induced Hypoglycemia
Lead Sponsor:
UNEEG Medical A/S
Conditions:
Sleep EEG
Eligibility:
All Genders
18-70 years
Brief Summary
Hypoglycaemia is associated with characteristic changes in the EEG with the appearance of slow frequency waves. In a recent study the investigators have shown that these changes can be recorded from s...
Detailed Description
The different sleep stages are associated with specific EEG-changes of high complexity with the occurrence of slow frequency waves during stages of deep sleep. The aim of this study is to assess EEG ...
Eligibility Criteria
Inclusion
- Type 1 diabetes patients
- Hypoglycemia unawareness
- aged 18-70
Exclusion
- Severe cardiac disease
- History of myocardial infarction
- Cardiac arrhythmia
- Previous stroke or cerebral haemorrhage and any other structural cerebral disease
- Active cancer or cancer diagnosis within the past five years
- Uremia defined as s-creatinine above 3 times upper reference value
- Liver disease defined as s-ALAT above 3 times upper reference interval
- Inability to understand the informed consent
- Epilepsy
- Use of antiepileptic drugs for any purposes
- Clinical important hearing impairment
- Use of active implantable medical device including
- Pacemaker and ICD-unit
- Cochlear implant
- Use of following drugs
- Chemotherapeutic drugs of any kind
- Methotrexate
- Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
- Abuse of alcohol (defined as consumption of \> 250g alcohol (in Danish: 21 "genstande") per week or abuse of any other neuroactive substances
- Infection at the site of device-implantation
- Any hemorrhagic disease
- Diving (snorkel diving allowed) or parachute jumping
- Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01237509
Start Date
January 1 2009
End Date
June 1 2010
Last Update
March 20 2015
Active Locations (1)
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1
Esbjerg Sygehus
Esbjerg, Denmark, 6700