This double blind randomized controlled study will enroll 20 subjects and will be conducted remotely. The study will be randomized for an 8-week period with a 1:1 active to sham device allocation. Primary endpoint analysis will be performed at 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
The device utilizes a technology called vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.
Insomnia Severity Index (ISI) score
To evaluate the effect of the Modius Sleep device, relative to control group on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia.
Time frame: 4 weeks
PCL-5 Score
To evaluate the effect of the Modius Sleep device, relative to control group, on the symptoms of PTSD, quantified by change in the PCL-5 Score.
Time frame: 4 weeks
SF-36 Score
To evaluate the effect of the Modius Sleep device, relative to control group, on quality of life, quantified by change in the SF-36 Score.
Time frame: 4 weeks
Generalised Anxiety Disorder (GAD-7) Scores
To evaluate the effect of the Modius Sleep device, relative to control group, on anxiety, quantified by change in the GAD-7 score. GAD-7 is a self-report rating scale assessing the severity of anxiety (range 0-21), with higher score indicating more severe anxiety.
Time frame: 4 weeks
Prescription reduction
To evaluate the effect of the Modius Sleep device, relative to control group, on prescription reduction, quantified by change in medication.
Time frame: 4 weeks
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