Sleep QualityNCT07027657
EXOMIND (BTL-699-2) for the Improvement of Sleep Quality and Reduction of Stress
A study testing Treatment with BTL-699-2 in people with Sleep Quality and Stress Reduction, run by BTL Industries Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Stress Reduction
- What is being tested?
- Treatment with BTL-699-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 May 2025to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Concurrent use of electroconvulsive therapy or vagus nerve stimulation
- Substance-induced depression or depression secondary to a general medical condition
- Seasonal affective disorder
- Substance abuse, obsessive compulsive disorder or post-traumatic stress disorder, major depression
- Psychotic disorder including schizoaffective disorder, bipolar disease or major depression with psychotic features
- Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia or movement disorders
- History of increased intracranial pressure or head trauma
- Nursing
- Usage of prescription sleep medication, Valerian of St. John's Wort in the past 2 months
- Usage of over-the-counter pills 5 or more times a week
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AntiAging and Wellness
Chula Vista, California, 91914
Kind Health Group
Encinitas, California, 92024
Minooka Healthcare Center
Minooka, Illinois, 60447
About this study
Official title: Safety and Efficacy of BTL-699-2 for the Improvement of Sleep Quality and Reduction of Stress
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
Read the 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
- Being tested
- Treatment with BTL-699-2, Treatment with BTL-699-2 (sham)
- Keywords
- rTMS, TMS, Sleep Quality, Stress Reduction, ExoTMS, EXOMIND
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-699-2Device
Also called ExoTMS, EXOMIND
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.
Treatment with BTL-699-2 (sham)Device
Also called ExoTMS, EXOMIND
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Treatment with BTL-699-2 (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start2 May 2025
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027657
- Sponsor's protocol ID
- BTL-699_CTUS300
- Status last verified
- Mar 2026
- First submitted
- 11 Jun 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of BTL-699-2 for the Improvement of Sleep Quality and Reduction of Stress
- ClinicalTrials.gov ID
- NCT07027657
- Acronym / sponsor ID
- BTL-699_CTUS300
- Conditions
- Sleep Quality, Stress Reduction
- Keywords
- rTMS, TMS, Sleep Quality, Stress Reduction, ExoTMS, EXOMIND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 May 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group A - active | Active comparator | Device: Treatment with BTL-699-2Group A will receive transcranial magnetic stimulation treatment with the intensity of up to 70% of their motor treshold with the BTL-699-2 device. |
| Group B - sham | Sham comparator | Device: Treatment with BTL-699-2 (sham)Group B will receive transcranial magnetic stimulation treatment with the intensity of 5% of their motor treshold with the BTL-699-2 device. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with BTL-699-2Also: ExoTMS, EXOMINDSix 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 | Group A - active |
| Treatment with BTL-699-2 (sham)Also: ExoTMS, EXOMINDSix 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. | Device | Group B - sham |
Primary outcome
Assessment of Sleep Quality Improvement
Time frame: 15 months
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.
5 secondary outcomes
Assessment of Stress
Time frame: 15 months
Sleep and Stress Assessment Questionnaire
Time frame: 15 months
Assessment of Therapy Comfort
Time frame: 15 months
Assessment of Satisfaction
Time frame: 15 months
Incidence of Treatment-related Adverse Events
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BTL-699-2 in people with Sleep Quality and Stress Reduction, run by BTL Industries Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Sleep Quality Improvement (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.