Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 12:36 PM
Study NCT ID:
NCT07027657
Status:
RECRUITING
Last Update Posted:
2025-07-21
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXOMIND (BTL-699-2) for the Improvement of Sleep Quality and Reduction of Stress
Sponsor:
BTL Industries Ltd.
Organization:
Study Overview
Official Title:
Safety and Efficacy of BTL-699-2 for the Improvement of Sleep Quality and Reduction of Stress
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: