| CTRI Number |
CTRI/2024/07/070580 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Eyewear Device] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The clinical study of Sleepaxa eyewear in the preventive treatment of common migraine.
|
|
Scientific Title of Study
|
Clinical validation of the efficacy of Sleepaxa eyewear in the preventive treatment of common migraine.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/013 Version No.: 1.00 Date: 13/06/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ninad Naik |
| Designation |
Consultant Physician |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth-Floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9637785567 |
| Fax |
- |
| Email |
doctorninaad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Ganu |
| Designation |
Managing Director |
| Affiliation |
Mprex Healthcare Pvt. Ltd. |
| Address |
Fifth-floor Office Number 501 and 514 Crossroads Bhumkar Square
Wakad
Pune
MAHARASHTRA
411057
India |
| Phone |
8554912644 |
| Fax |
- |
| Email |
drgayatri@mprex.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Suraj Arun Dubey |
| Designation |
Director |
| Affiliation |
Sleepaxa Private Limited |
| Address |
D-205 Swastik Residency BH Dena Bank
Surat
GUJARAT
395010
India |
| Phone |
9624001789 |
| Fax |
- |
| Email |
sleepaxa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sleepaxa Private Limited, D-205 Swastik Residency, BH Dena Bank, Surat, Gujarat State, India, 395010 |
|
|
Primary Sponsor
|
| Name |
Sleepaxa Private Limited |
| Address |
D-205 Swastik Residency BH Dena Bank, Surat, GUJARAT 395010, India
|
| Type of Sponsor |
Other [Eyewear Industry] |
|
|
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 Ninad Naik |
Lokmanya Medical Research Centre and Hospital |
Fourth-floor OPD 401
314 B Telco Road
Chinchwad
Pune
MAHARASHTRA |
9637785567
-
doctorninaad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sleepaxa eyewear |
Wear Sleepaxa Migraine Glasses just like regular eyeglasses for 28 days. They can be worn throughout the day to provide continuous protection against migraine triggers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with a history of migraine without aura for at least 6 months prior to the screening visit for the study 2.Patients with light sensitivity and eye fatigue due to migraine 3.Patients experiencing 2-6 migraine attacks per month, but not more than 15 headache days per month 4.Male or female patients aged 18 to 60 years (both inclusive) 5.Patients willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients have more than 15 headache days per month or less than 2 migraine attacks per month
2. Patients have more than 6 attacks per year of migraine with aura
3. Pregnant women or nursing mothers
4. Women of child-bearing potential & all men not willing to follow a reliable & effective contraceptive measure during the course of the study
5. Patients headache attacks are associated with or attributable to an identifiable cause such as premenstrual period a disease of eye ear or nose a neurological disease or a psychiatric illness
6. Any known refractive errors.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Assessment of changes in the frequency of migraine headaches by using migraine diary/headache diary. |
Baseline, Day 7, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of changes in the intensity and duration of migraine headaches from baseline to end of the study.
2.Patient-reported assessments of changes in eye fatigue and light sensitivity using Visual Analog Scales (VAS) from screening to end of the study.
3.Proportion of patients achieving a greater than or equal to 50% reduction in migraine frequency from screening to end of the study.
4.Assessment of changes in perceived stress levels measured by the Perceived Stress Scale (PSS) from baseline to end of the study.
5.Assessment of changes in mood measured by the Profile of Mood States (POMS) questionnaire from baseline to end of the study.
|
Screening, Baseline, Day 7, Day 14, Day 28 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Sleepaxa Migraine Glasses are specialized eyewear designed to alleviate symptoms associated with migraines and light sensitivity. These glasses incorporate advanced FL-41 tint technology and blue-block technology to provide comprehensive protection against harmful light wavelengths. The FL-41 tint, a mild rose tint, has been scientifically proven to reduce light sensitivity and photophobia by filtering out specific wavelengths of light, particularly in the blue-green spectrum (480-520 nm), which are known to exacerbate migraine symptoms. By reducing the amount of light that reaches the visual cortex, these glasses help in soothing and mitigating migraine symptoms, providing significant relief to sufferers. Blue-block technology in Sleepaxa Migraine Glasses is specifically designed to block high-energy visible (HEV) blue light. The glasses effectively filter out wavelengths in the range of 400-450 nm, which are associated with digital eye strain and can trigger migraines. This technology helps in preventing over-stimulation of the retinal cells, thereby reducing the risk of migraine onset and easing existing symptoms. Given the debilitating nature of migraines and the limitations of current treatment options, there is a clear need for innovative and effective non-pharmacological interventions. Sleepaxa Migraine Glasses offer a promising solution by addressing the photophobia and light sensitivity that often accompany migraines. The purpose of this study is to clinically validate the efficacy and safety of Sleepaxa Migraine Glasses in the preventive treatment of common migraine. By evaluating the reduction in migraine frequency, intensity, and duration, as well as improvements in eye fatigue, light sensitivity, stress, and mood, this study aims to provide robust evidence for the effectiveness of Sleepaxa Migraine Glasses as a preventive treatment for migraines. |