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

NCT07027657 | Completed FDA Device

• 1 other identifier: BTL-699_CTUS300
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Sleep Quality; Stress Reduction

Keywords

rTMS; TMS; Sleep Quality; Stress Reduction; ExoTMS; EXOMIND

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Assessment of Stress

  15 months

• Sleep and Stress Assessment Questionnaire

  15 months

• Assessment of Therapy Comfort

  15 months

• Assessment of Satisfaction

  15 months

• Incidence of Treatment-related Adverse Events

  15 months

Study Arms (2)

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.

Device: Treatment with BTL-699-2

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.

Device: Treatment with BTL-699-2 (sham)

Interventions

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.

Also known as: ExoTMS, EXOMIND

Group A - active

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.

Also known as: ExoTMS, EXOMIND

Group B - sham

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 22 years
• The minimal pre-treatment PSQI score of \>= 5 points
• Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in sleep quality and reduction of stress, including non-invasive brain stimulation treatments other than the study procedure during study participation
• Subjects willing and able to maintain their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
• Willingness to comply with study instructions and to return to the clinic for the required visits
• Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study
• If applicable, subjects will be maintained on pre-study prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry
• Subject is not using any sleeping medication or is using over-the-counter pills (except Valerian and St. John's Wort) no more than 4 times a week

You may not qualify if:

• Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators
• Metallic, ferromagnetic or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 in (30 cm) of the therapy coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes and tattoos with metallic ink),
• Drug pumps (within 12 in (30 cm) of the therapy coil)
• Application in the heart area
• Persons with a tendency to seizure (hypotonic, epileptic)
• Ongoing anticoagulation therapy
• Ongoing severe or life-threatening condition
• Pulmonary insufficiency
• Heart disorders
• Renal insufficiency
• Decompensated\* hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
• Malignant tumor, benign tumor
• Fever
• Ongoing pregnancy
• Suicidal tendencies or recent attempt to commit suicide

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

AntiAging and Wellness

Chula Vista, California, 91914, United States

Location

Kind Health Group

Encinitas, California, 92024, United States

Location

Minooka Healthcare Center

Minooka, Illinois, 60447, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 18, 2025
• Study Start: May 2, 2025
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (3)