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Clinical Trials/CTRI/2026/04/108095
CTRI/2026/04/108095Not yet recruitingNot Applicable

EFFECT OF SLEEP HYGIENE INTERVENTION ON CLINICAL OUTCOMES IN PATIENTS WITH PRIMARY MIGRAINE - A RANDOMIZED CONTROLLED TRIAL

Kamlesh Chandra1 site in 1 country70 target enrollmentStarted: May 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
70
Locations
1

Study Overview

Brief Summary

Migraine is a common neurological disorder that significantly affects quality of life. Poor sleep quality is an important trigger for migraine attacks. Sleep hygiene intervention is a non pharmacological, cost effective method that may improve sleep quality and reduce migraine severity.

This study aims to assess the effect of sleep hygiene intervention on clinical outcomes in patients with primary migraine. The study will be conducted among diagnosed migraine patients. Baseline assessment of sleep quality using Pittsburgh Sleep Quality Index and migraine characteristics will be done.

Participants will receive structured sleep hygiene education. Follow up will be done after 3 months to assess improvement in sleep quality, reduction in frequency and duration of migraine attacks and reduction in use of analgesics.

The findings of this study may help in establishing sleep hygiene as an effective intervention in management of migraine patients.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Aged 18 to 60 years Diagnosed with Primary Migraine according to ICHD-3 Experiencing 4–15 migraine days per month (episodic migraine) Willing to adhere to weekly intervention sessions and daily home practice Willing to give written informed consent.

Exclusion Criteria

  • Diagnosed with secondary headache disorder (eg cluster headache medication overuse headache) Severe psychiatric co morbidities as per DSM 5 History of substance abuse or dependency Currently practicing regular meditation or participating in any.

Investigators

Sponsor
Kamlesh Chandra
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Kamlesh Chandra

Ganesh shankar Vidyarthi Memorial Medical College Kanpur

Study Sites (1)

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