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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - active | Active Comparator | Group A will receive transcranial magnetic stimulation treatment with the intensity of up to 70% of their motor treshold with the BTL-699-2 device. |
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| Group B - sham | Sham Comparator | Group B will receive transcranial magnetic stimulation treatment with the intensity of 5% of their motor treshold with the BTL-699-2 device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with BTL-699-2 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AntiAging and Wellness | Chula Vista | California | 91914 | United States | ||
| Kind Health Group |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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All patients will be randomly divided into 2 study groups - Group A and Group B (sham). The allocation of subjects into study groups will be in ratio 3:1 (Group A:Group B).
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Only the subject will be unaware of the group assignment. The operator providing the treatment will be aware of the subject's group assignment and will perform the treatment with the setting according to the subject's group.
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| Treatment with BTL-699-2 (sham) | Device | 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. |
|
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| 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. | 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. | 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. | 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. | 15 months |
| Encinitas |
| California |
| 92024 |
| United States |
| Minooka Healthcare Center | Minooka | Illinois | 60447 | United States |
| D001523 |
| Mental Disorders |