The goal of this clinical trial is to evaluate whether the treatment with BTL-699-2 device is able to improve sleep quality and reduce stress in adults above the age of 22 years. The main questions it aims to answer are: Does the treatment with BTL-699-2 device improve sleep quality? Does the treatment with BTL-699-2 device reduce stress? Participants will be asked to: * Undergo six treatments * Complete the Pittsburgh Sleep Quality Index * Complete the Perceived Stress Scale Questionnaire * Complete the Sleep and Stress Assessment Questionnaire * Complete the Therapy Comfort and Subject Satisfaction Questionnaire
The study uses a multi-center, sham-controlled, single-blinded, interventional study design. The subjects will be enrolled and assigned to two experimental study arms - Group A and Group B in the ratio 3:1. Group A will receive active treatment and Group B, which received sham treatment, will serve as a control. All enrolled participants will receive six treatment visits, 3-7 days apart. The Pittsburgh Sleep Quality Index, Perceived Stress Scale Questionnaire and Sleep and Stress Assessment Questionnaire will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits - 1 month and 3 months after the final session. The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction will be given after the last treatment and at both follow-up visits. The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
Six transcranial magnetic stimulation treatments with the BTL-699-2 device will be delivered over the left dorsolateral prefrontal cortex, spaced 3 to 7 days apart. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold.
Six transcranial magnetic stimulation treatments with the BTL-699-2 device will be delivered over the left dorsolateral prefrontal cortex, spaced 3 to 7 days apart. The intensity will be adjusted according to the subject's feedback, up to 5% of the individual's motor threshold.
AntiAging and Wellness
Chula Vista, California, United States
Kind Health Group
Encinitas, California, United States
Minooka Healthcare Center
Minooka, Illinois, United States
Assessment of Sleep Quality Improvement
The change in the score obtained from the Pittsburgh Sleep Quality Index will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, at the 1-month and 3-month follow-up visits. It is a 19-item questionnaire. These 19 questions are grouped into 7 components, and each component is scored on a 0 - 3 scale. The minimum obtained score is 0 and the maximum is 21. Lower score indicates healthier sleep quality, therefore improvement is considered a decrease in the obtained score.
Time frame: 15 months
Assessment of Stress
Evaluation of a change in the score obtained from the Perceived Stress Scale for the assessment of the stress reduction potential. The questionnaire will be administered at the baseline visit, after the last treatment, at the 1-month and 3-month follow-up visits. Each question is rated on a 0 - 4 scale, where 0 = never, and 4 = very often. The minimum obtained score is 0 and the maximum is 40. Higher scores indicate higher levels of perceived stress.
Time frame: 15 months
Sleep and Stress Assessment Questionnaire
Sleep and Stress Assessment Questionnaire is a self-report questionnaire used to provide more insight into sleep and stress medication use and stress levels. Subjects will be asked to fill in the questionnaire at the baseline visit, after the last treatment, at 1-month and 3-month follow-up visits. The baseline questionnaire consists of 5 items, while the versions administered after the last treatment and at follow-up visits contain 6 items. The questionnaire is not scored; instead, it includes yes/no and open-ended questions to capture qualitative information on sleep and stress-related factors.
Time frame: 15 months
Assessment of Therapy Comfort
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree") and the 10-point Numeric Analog Scale for pain (0 = "no pain", 10 = "worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Analog Scale for pain indicate higher therapy comfort.
Time frame: 15 months
Assessment of Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction. The questionnaire will be administered after the last treatment, at the 1-month and 3-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly disagree" (1 point) to "strongly agree" (5 points). A higher score for each statement indicate better outcomes.
Time frame: 15 months
Incidence of Treatment-related Adverse Events
Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the treatment with the BTL-699-2 device for the improvement of sleep and reduction of stress and to identify side effects and adverse events associated with the study treatment.
Time frame: 15 months
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