The purpose of this study is to investigate the ability of a translational device, Teledyne PeakSleep, to reduce sleep onset latency, reduce time awake after sleep onset and improve restfulness and the subjective benefits of sleep in a patient population with insomnia via transcranial direct current stimulation (tDCS) applied to frontal lobe circuits.
The purpose of this research study is to investigate a new, targeted intervention to improve outcomes for those suffering from insomnia by attempting to enhance the brain rhythms within the frontal lobe implicated in slow wave generation during the transition from wake to sleep. The device applies a pulsed trapezoidal direct current waveform at 0.75 Hz to the frontal areas of the brain immediately prior to attempted sleep onset to facilitate the transition to sleep. During this cross-over trial, patients will be asked to use a PeakSleep wearable neurotechnology prototype headband, which delivers \<14 minutes of frontal tDCS over a 30-minute period, immediately before trying to fall asleep. Using an active stimulation versus sham paradigm, we will compare actigraphy data, physiological data, and subjective sleep measures against a pre-treatment baseline in the same patient. Participants will complete five in-person visits over the course of the 8-week study. The first visit includes the collection of baseline self-reported data and actigraphy device training. All subsequent visits involve headset training, downloading PeakSleep and actigraphy data, repeating self-reported data measures, and reporting user experience with the device. Participants will not perform any formal sleep study visits and instead provide daily actigraphy data via a FitBit and EEG data when wearing PeakSleep in their own home.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
The PeakSleepTM is a constant current device which delivers stable stimulation as a function of the impedance measured across the electrodes (e.g. it varies voltage to produce a steady current). The device gradually ramps up the current as the impedance decreases during the stimulation session. The device uses stimulation amplitudes in the range of 100uA to 500uA at each electrode pair. Devices will be configured to deliver 100 stimulation trains over 30 minutes where each train is 6 pulses of 0.75Hz trapezoidal stimulation (each train lasts 8 seconds). The inter-train interval is 10 seconds leading to a total stimulation time of \<14 minutes with a maximum dose of 1mA (500uA per electrode pair).
Sham is delivered with the same devices which are alternatively configured to deliver a trivially low amplitude (e.g. 100uA) waveform of a different frequency (e.g. 25 Hz) for the same treatment duration. Beyond differences in amplitude and frequency of stimulation, devices will be operated in exactly the same way during sham treatment.
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Sleep Onset Latency Change from Baseline
FitBit actigraphy data will be collected to measure daily sleep onset latency (SOL) for two weeks at baseline (weeks 1-2, averaged) and compared to that of the study period (weeks 3-5).
Time frame: 5 weeks
ISI Change from Baseline
The Insomnia Severity Index (score from 0-28, higher is worse insomnia) will capture sleep habits and insomnia symptomatology during experimental sessions. Compared across pre-screen and 5 visit blocks.
Time frame: 5 weeks
PHQ-9 Change from Baseline
The Patient Health Questionnaire (PHQ-9, score from 0-27, higher is worse depression) will assess psychiatric conditions at visits 1, 3, and 5.
Time frame: 5 weeks
Total Sleep Time Change from Baseline
FitBit actigraphy data will be collected to measure total sleep time (TST) and time awake after sleep onset (WASO) during the first treatment block, for two weeks. During weeks 3-5.
Time frame: 5 weeks
EEG spectral changes from baseline (Delta power increase)
The PeakSleep device contains 3 EEG sensors (approximately Fp1, Fpz, Fp2) which will collect EEG data for investigation of neural activity for both stimulation and sham conditions. Will occur nightly for two weeks during Treatment 1 (i.e., weeks 3-4).
Time frame: 5 weeks
Heart rate variability change from baseline
For two weeks during treatment 1, heart rate will be collected daily via FitBit. Averages will be averages compared across treatment blocks (baseline, treatment 1, washout, treatment 2)
Time frame: 5 weeks
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