| CTRI Number |
CTRI/2026/01/102521 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Non-invasive Treatment for Insomnia disorder. |
|
Scientific Title of Study
|
Safety and Efficacy of Non-Invasive Treatment for Insomnia disorder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Saravanan |
| Designation |
Consultant Neurologist |
| Affiliation |
Sagar Hospitals, Bengaluru |
| Address |
Sagar Hospitals,
1st Floor, Room No. N4, Neurology department
No.44/54, 30th Cross Rd, Extension, 4th T Block East,
Tilak Nagar, Jayanagar, Bengaluru, Karnataka,India
Bangalore
KARNATAKA
560041
India |
| Phone |
9845507322 |
| Fax |
|
| Email |
Dr.saravanan.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Saravanan |
| Designation |
Consultant Neurologist |
| Affiliation |
Sagar Hospitals, Bengaluru |
| Address |
Sagar Hospitals,
1st Floor, Room No. N4, Neurology department
No.44/54, 30th Cross Rd, Extension, 4th T Block East,
Tilak Nagar, Jayanagar, Bengaluru, Karnataka,India
Bangalore
KARNATAKA
560041
India |
| Phone |
9845507322 |
| Fax |
|
| Email |
Dr.saravanan.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Saravanan |
| Designation |
Consultant Neurologist |
| Affiliation |
Sagar Hospitals, Bengaluru |
| Address |
Sagar Hospitals,
1st Floor, Room No. N4, Neurology department
No.44/54, 30th Cross Rd, Extension, 4th T Block East,
Tilak Nagar, Jayanagar, Bengaluru, Karnataka,India
Bangalore
KARNATAKA
560041
India |
| Phone |
9845507322 |
| Fax |
|
| Email |
Dr.saravanan.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| BTL India Pvt Ltd
Address: 7th Floor, Tower 1, Umiya Business Bay,
Embassy Tech Square Main Rd, Kaverappa Layout,
Kadubeesanahalli, Kadubeesanahalli, Bengaluru |
|
|
Primary Sponsor
|
| Name |
BTL India Pvt Ltd |
| Address |
7th Floor, Tower 1, Umiya Business Bay,
Embassy Tech Square Main Rd, Kaverappa Layout,
Kadubeesanahalli, Kadubeesanahalli, Bengaluru, Karnataka 560103, India |
| Type of Sponsor |
Other [Medical device manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Saravanan |
Sagar Hospitals |
1st Floor, Room No. N4, Neurology department,No.44/54, 30th Cross Rd, Extension, 4th T Block East,
Tilak Nagar, Jayanagar, Bengaluru
Bangalore
KARNATAKA |
09845507322
Dr.saravanan.s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G47||Sleep disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BTL-699, applicator BTL-699-AP-M-2
|
The device is intended for the treatment of insomnia disorder.
The treatment administration phase will consist of six treatment visits spaced 2–7 days apart,
the duration of each treatment will be 24.5 minutes. The BTL-699-AP-M-2 applicator will
be positioned over the left prefrontal cortex. Intensity of the magnetic field will be based on the subject’s measured motor threshold.
The subjects will be assessed for adverse device effects resulting from the treatments with BTL-699 device during the whole course of the study starting with the first treatment.
The Insomnia Severity Index (ISI) will serve as the primary tool to assess insomnia severity.
Participants’ ISI scores at the 30-day follow-up will be compared with baseline values to determine the degree of improvement in insomnia severity. A decrease greater than 6 points
on the ISI from baseline to the 30-day follow-up will be documented as evidence of meeting the primary study objective, as this threshold reflects a minimally important change.11
The Pittsburgh Sleep Quality Index (PSQI) will be administered to evaluate broader aspects
of sleep quality. Changes in PSQI scores from baseline to the 30-day follow-up will provide additional insight into the impact of rTMS treatment on both nocturnal sleep and associated
daytime functioning. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
-Adult subjects aged 18 and older seeking treatment for insomnia disorder
-Sleep difficulties at least 3 nights per week
-Sleep difficulties have persisted for more than 3 months
-Subjects meet DSM-5 criteria for Insomnia Disorder
1.Predominant complaint of dissatisfaction with sleep quantity or quality,
associated with one (or more) of the following symptoms
-difficulty initiating sleep.
-difficulty maintaining sleep, characterized by frequent awakenings or
problems returning to sleep after awakening.
-Early-morning awakening with inability to return to sleep.
2.The sleep disturbance causes clinically significant distress or impairment in
social, occupational, educational, academic, behavioral, or other important
areas of functioning.
3.The insomnia is not better explained by and does not occur exclusively during
the course of another sleep-wake disorder such as narcolepsy, a
breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, or a
parasomnia.
4.Coexisting mental disorders and mental conditions do not adequately explain
the predominant complaint of insomnia.
5.The insomnia is not attributable to the physiological effects of a substance,
such as a drug of abuse or a medication.
-At least 15 points in Insomnia Severity Index (ISI)
-Subjects should be able to understand the investigative nature of the treatment, the
possible benefits and side effects, and must sign the Informed Consent Form.
-Subjects are willing and able to comply with protocol requirements, including
obtaining study-required assessments and returning for follow-up visits
-Subjects willing and able to abstain from partaking in any treatments other than the
study procedure (including prescribed or over-the-counter sleeping medication) to
treat insomnia disorder during study participation
-Subjects are willing not to travel to different time zones and to maintain a familiar
sleeping routine
-Women of childbearing potential are required to use birth control measures. |
|
| ExclusionCriteria |
| Details |
Any subject who is meeting any of the following criteria will be excluded from participation
in the study
1.Electronic implants
-implanted stimulator devices in or near the head; rTMS devices are contraindicated for use in patients who have active or inactive implants,
including device leads, deep brain stimulators, cochlear implants, ocular implants
-and vagus nerve stimulators, implanted devices such as cardiac pacemakers,
defibrillators, and neurostimulators or other electronic implants in or near the head
2.Metallic, ferromagnetic or other magnetic-sensitive implants or 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 the Safety Precautions and Warnings or within 30 cm (12 in) of the treatment coil (examples include implanted
electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments,
jewellery, and hair barrettes)
3.Application in the heart area
4.Persons with a tendency to seizures (e.g. persons suffering from hypotonia and
epilepsy)
5.Anticoagulation therapy
6.Severe or life-threatening condition
7.Renal dialysis therapy or decompensated renal insufficiency
8.Decompensated hemorrhagic conditions
9.Decompensated blood coagulation disorders
10.Decompensated cardiovascular diseases
11.Malignant tumor or benign tumor (within 30 cm of the treatment coil)
12.Fever
13.Application over or in the near proximity (within 30 cm of the treatment coil) of
tattoos with metallic ink
14.Suicidal tendencies or recent suicide attempt
15.Varying degrees of medication resistance
16.Concurrent use of electroconvulsive therapy or vagus nerve stimulation
17.Ongoing or recent changes (less than 30 days) in intake doses of any pharmaceutical
products, standalone or in combination, that might lower the threshold of seizure
potential
18.Ongoing withdrawal conditions from any dependence substance or medication
associated with an altered seizure risk history
19.A psychotic disorder, including schizoaffective disorder, bipolar disease, or major
depression with psychotic features
20.History of primary or secondary tumors in the CNS, cerebral aneurysm
21.History of increased intracranial pressure or head trauma with loss of consciousness
22.Ongoing pregnancy or breastfeeding
23.Presence of other sleep disorders (as evaluated by specific questions from structured interview)e.g.sleep apnea, periodic leg movements while sleeping, or parasomnias)
24.Presence of clinically significant psychiatric disorders,e.g. schizophrenic and
affective psychotic spectrum disorders, organic brain diseases with psychotic
symptoms, post-traumatic stress disorder, addictions.
25.Any other disease or condition at the investigator discretion that may pose a risk to
the patient or compromise the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The change (decrease) in Insomnia Severity Index (ISI) score at the 30-day follow-up greater than 6 points when compared to the baseline value.
|
At the baseline visit, before the first
study treatment, subjects will be examined to confirm inclusion and exclusioncriteria. Upon
verification of the inclusion/exclusion criteria, the subjects will be required tocomplete six
treatments spaced 2–7 days apart and one follow-up visit 30 days after the lasttreatment.
The approximate subject participation duration is 3 months after the enrollment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The change (decrease) in Pittsburgh Sleep quality index (PSQI) total score from
baseline to the 30-day follow-up assessment.
2.At least 80 percent of the treated subjects to report satisfaction (level satisfied or very
satisfied) with the therapy outcome at 30-day follow-up using the Subject Satisfaction
Questionnaire.
3.Evaluation of the therapy comfort during the therapy with BTL-699 device via the
Therapy comfort questionnaire.
|
At the baseline visit, before the first
study treatment, subjects will be examined to confirm inclusion and exclusion criteria. Upon
verification of the inclusion/exclusion criteria, the subjects will be required to complete six
treatments spaced 2–7 days apart and one follow-up visit 30 days after the last treatment.
The approximate subject participation duration is 3 months after the enrollment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objectives: Primary objective(s): The primary objective of the study is to demonstrate that BTL-699 is safe and effective in treating the insomnia disorder. Secondary objective(s): 1.To evaluate participants’ global sleep quality and daytime functioning 2.To evaluate participants’ satisfaction with the therapy. 3.To evaluate participants’ comfort with the therapy.
Type of the study: Prospective, open-label, one-arm, single-center, interventional study.
Intended purpose of the investigational device: The BTL-699 is intended for the treatment of insomnia disorder.
Intended population and indications for use: The device is intended for adults only excluding pregnant or breastfeeding women. The patient must not show any signs of contraindications. Before applying the therapy, it is necessary to consider the patient’s medical history and examine the patient thoroughly to determine whether or not the application of therapy is suitable for the patient. A special population where the safety and effectiveness of the therapy has not been established is defined in the chapter Special population of the User’s manual.
|