None listed
Conditions
Brief summary
This is a proof of concept trial to deliver an early pharmacological intervention to enhance sleep spindle EEG features to optimise sleep quality and improve memory in those presenting with subjective memory complaints. Participants will receive a short-acting, non-benzodiazepine zolpidem or a placebo immediately prior to an overnight 8 hour sleep opportunity in a randomised order with a 5 to 10 day washout at the Woolcock Institute’s sleep and chronobiology laboratory using high-density electroencephalography (EEG). It will be hypothesized that memory consolidation will be significantly better with active drug compared to placebo.
Interventions
This proof of concept study will test a drug intervention to boost sleep spindle brain activity during non-REM sleep and to improve memory consolidation in cognitively-intact older adults.
Zolpidem (5mg) a short-acting, non-benzodiazepine, will be administered orally. Zolpidem is a widely prescribed hypnotic, has a low risk of dependence, fewer side effects than benzodiazepines and is safe for long-term use.
Zolpidem and placebo will be administered orally in the evening prior to the 8-hour
This proof of concept study will test a drug intervention to boost sleep spindle brain activity during non-REM sleep and to improve memory consolidation in cognitively-intact older adults. Zolpidem (5mg) a short-acting, non-benzodiazepine, will be administered orally. Zolpidem is a widely prescribed hypnotic, has a low risk of dependence, fewer side effects than benzodiazepines and is safe for long-term use. Zolpidem and placebo will be administered orally in the evening prior to the 8-hour sleep opportunity on two nights in a randomised order with a 5-10 day washout between administration. Participants’ sleep will be monitored in an overnight study in the laboratory using high-density electroencephalography (EEG).
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males and Females; 2. Age 50-75; 3. Ability to perform neurobehavioural tests; 4. Able to give informed consent; 5. Fluent in English; 6. Cognitively intact (may have subjective memory complaint)
Exclusion criteria
1. Mild cognitive impairment, suspected or confirmed dementia or Mini Mental State Examination <24 ; 2. History of cerebrovascular events (e.g. stroke, TIA) associated with persisting cognitive changes 3. Neurological disorders (e.g. Parkinson’s Disease, Epilepsy, Multiple Sclerosis) 4. Myasthenia Gravis 5. Severe hepatic impairment 6. Acute ± severe pulmonary insufficiency 7. Head trauma with associated loss of consciousness > 30 mins 8. Psychiatric disorder including; Bipolar Disorder (I and II) and schizophrenia 9. Current major depressive episode 10. Currently regularly taking regular benzodiazepines, sedatives and hypnotics, and other sleep-affecting medications or any centrally active medications including anti-depressants /polypharmacy. 11. Current substance abuse or dependence (alcohol and/or other illicit substances) 12. Shift-work or trans-meridian travel within 14 days of assessment 13. Obstructive Sleep Apnoea and other sleep disorders; 14. Severe insomnia (insomnia severity index score of 22 or more) 15. Contraindication to MRI scanning. 16. Clinically significant medical condition that may hinder compliance with protocol as determined by the study physician. 17. Pregnancy
Outcome results
None listed