Insomnia, Sleep Disturbance
Conditions
Keywords
transcranial electrical stimulation
Brief summary
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.
Detailed description
Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required. Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.
Interventions
DEVICETranscranial Electrical Neuromodulation (TES)
TES phase-aligned with slow waves or not
Sponsors
Brain Electrophysiology Laboratory Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The phase alignment of the treatment is set in software and not revealed to participant or experimenter. Order of treatment is randomized and counterbalanced.
Intervention model description
Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy adults
Exclusion criteria
* persons with epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slow wave amplitude | Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night. | Amplitude of slow waves of sleep |
| Slow wave duration | Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night. | Duration of slow wave period in sleep |
Countries
United States
Contacts
Primary ContactDon M Tucker, PhD
Backup ContactPhan Luu, PhD
Outcome results
None listed