None listed
Conditions
Brief summary
This study investigates whether non-invasive, electrical stimulation delivered at a specific area of the skin associated with a pathway to a part of the brain responsible for producing melatonin can subsequently alter melatonin levels and therefore, influence sleep. Healthy adult, male volunteers between 18-55 years old will be recruited. We employ two different frequencies (10 Hz and 80 Hz) and a sham stimulation as a control measure to investigate our hypothesis. It is hypothesised that these two different frequencies may exert opposite effects.
Interventions
The sleep hygiene of healthy adult, male participants, between 18-55 years old is appraised for three nights prior to the experimental intervention. Participants’ sleep hygiene will be assessed via both subjective and objective measures. The subjective measures will be recorded via the use of a sleep diary which records subjective reporting of information pertaining to sleep time, wake time, time spent asleep, number of awakenings, length of time spent awake, ease of falling asleep, sleep distur
The sleep hygiene of healthy adult, male participants, between 18-55 years old is appraised for three nights prior to the experimental intervention. Participants’ sleep hygiene will be assessed via both subjective and objective measures. The subjective measures will be recorded via the use of a sleep diary which records subjective reporting of information pertaining to sleep time, wake time, time spent asleep, number of awakenings, length of time spent awake, ease of falling asleep, sleep disturbance, feeling of refreshment following awakening, caffeine and alcohol consumption, heavy meal consumption 2-3 hours prior to sleep, the likelihood of daytime dozing, and mood. Objective measures obtained from the wrist-worn actigraph devices include: sleep time, wake time, sleep duration, sleep onset latency, wake after sleep onset, sleep efficiency, light exposure, and any time the actigraph device was not worn. If participants’ sleep hygiene is assessed as suitable for the study, they progress to the experimental phase. The experimental phase consists of a researcher-lead stimulation session during the day and a participant-lead stimulation session during the night. Each stimulation frequency is applied for one day time and one night time phase. For the experimental phase during the day, measures of sleepiness, pupil diameter, and blood flow changes are captured using electroencephalography (EEG), eye-tracker glasses, and pulse oximetry, respectively. These measures are used before, during, and after 10 minutes of transcutaneous electrical nerve stimulation (TENS) delivered at the C2 dermatome. Saliva samples are collected before and after stimulation. The experimental phase during the night is conducted in participants’ homes. Here, they self-administer TENS stimulation at the C2 dermatome for 10 minutes. Saliva samples are self-collected before and after stimulation. Participants record the times they sit down in dim light, collect each saliva sample, and begin and end stimulation. Each stimulation frequency is applied for one day time and one night time phase. Participants record the times they sit down in dim light, collect each saliva sample, and begin and end stimulation. Following stimulation in either the day or the night, participants will record sleep/wake information in a sleep diary and sleep wearing a single-channel EEG and a wrist-worn actigraphy device in order to assess their sleep. Participants cycle through stimulation at: 10 Hz, 80 Hz, or sham stimulation. All stimulation frequencies (including sham) are performed both during the daytime, researcher-lead phase and the night-time participant-lead phase. These phases are conducted on separate days with a one-day washout period in between. The washout period between stimulation frequencies and/or sham stimulation is two-days.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy, (no neurological/cognitive impairments and not on any regular medication) male volunteers between the ages of 18 and 55 years old, with good sleep hygiene and no problems associated with sleep.
Exclusion criteria
Not consume more than 2 alcoholic drinks per day, not regularly use any recreational drugs, no history of serious medical conditions, no vision impairments other than glasses/contact lenses, no allergies, no plans to travel across time zones or undertake shift work in the next month, not work shifts, not excessively consume caffeine (approx. >6 cups of coffee per day).
Outcome results
None listed