Losing sleep over Alzheimer*s disease? Effects of sleep deprivation on cerebrospinal fluid amyloid-beta dynamics

Losing sleep over Alzheimer*s disease? Effects of sleep deprivation on cerebrospinal fluid amyloid-beta dynamics - AWAKE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36421

Enrollment

Registered

2011-03-08

Start date

2011-05-11

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurodegeneratieve hersenaandoening Alzheimer's dementia Alzheimer's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Written informed consent -Age 40-60 years -Male -Subject is in good health as established by medical history, physical examination, ECG and laboratory examination -Laboratory parameters (as described on in section 3.7 screening) should be within the normal ranges as applicable in RUNMC, Nijmegen, or clinically acceptable to the investigator -Normal sleep behaviour, Pittsburg Sleep Quality index score

Exclusion criteria

Exclusion criteria: -Presence of blood coagulopathy, established by medical history -Allergy to local anesthetic agents -Contra-indication for spinal catheter placement: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine -Subjects who are currently participating in another study or have participated in a clinical study within 30 days, based on their own report about participation history -Subjects with a history of drug or alcohol abuse in the past -Subjects who are part of the study staff personnel or family members of the study staff personnel

Design outcomes

Primary

Measure	Time frame
In the intervention group CSF Aβ42 concentrations taken at 10 time points before, during and after sleep deprivation, and in the control group at 6 time points before and after the control night with unrestricted sleep.	—

Secondary

Measure	Time frame
-The concentrations of CSF Aβ40, t-tau, p-tau and hypocretin at 10 time points in the intervention group and at 6 time points in the control group. -The scores of continuous EEG measurements indicating quality of sleep and the different sleep stages during the control night and registering if any sleep occurred during the sleep deprivation night. -Hemodynamic parameters, heart rate and beat-to-beat blood pressure for 5 subsequent minutes at 6 time points during the study.	—

Measure

Time frame

-The concentrations of CSF Aβ40, t-tau, p-tau and hypocretin at 10 time points in the intervention group and at 6 time points in the control group. -The scores of continuous EEG measurements indicating quality of sleep and the different sleep stages during the control night and registering if any sleep occurred during the sleep deprivation night. -Hemodynamic parameters, heart rate and beat-to-beat blood pressure for 5 subsequent minutes at 6 time points during the study.

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Countries

Netherlands

Outcome results