NCT07027657

EXOMIND (BTL-699-2) for the Improvement of Sleep Quality and Reduction of Stress

Safety and Efficacy of BTL-699-2 for the Improvement of Sleep Quality and Reduction of Stress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Sleep Quality
• Stress Reduction

Interventions

Type	Name	Description
DEVICE	Treatment with BTL-699-2	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.
DEVICE	Treatment with BTL-699-2 (sham)	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.

Timeline

• Start date: 2025-05-02
• Primary completion: 2025-11-11
• Completion: 2025-11-11
• First posted: 2025-06-18
• Last updated: 2026-03-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study