The clinical study of Sleepaxa eyewear in the preventive treatment of common migraine.

Not Applicable

Conditions: Health Condition 1: G430- Migraine without aura

Registration Number: CTRI/2024/07/070580

Lead Sponsor: Sleepaxa Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of changes in the frequency of migraine headaches by using migraine diary/headache diary.Timepoint: Baseline, Day 7, Day 14, Day 28

Secondary Outcome Measures

Name	Time	Method
1.Assessment of changes in the intensity and duration of migraine headaches from baseline to end of the study. <br/ ><br>2.Patient-reported assessments of changes in eye fatigue and light sensitivity using Visual Analog Scales (VAS) from screening to end of the study. <br/ ><br>3.Proportion of patients achieving a greater than or equal to 50% reduction in migraine frequency from screening to end of the study. <br/ ><br>4.Assessment of changes in perceived stress levels measured by the Perceived Stress Scale (PSS) from baseline to end of the study. <br/ ><br>5.Assessment of changes in mood measured by the Profile of Mood States (POMS) questionnaire from baseline to end of the study. <br/ ><br>Timepoint: Screening, Baseline, Day 7, Day 14, Day 28