| CTRI Number |
CTRI/2026/04/108095 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
effect of sleep hygiene in patients with primary migraine |
|
Scientific Title of Study
|
EFFECT OF SLEEP HYGIENE INTERVENTION ON CLINICAL OUTCOMES IN PATIENTS WITH PRIMARY MIGRAINE - A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kamlesh Chandra |
| Designation |
Junior Resident |
| Affiliation |
Ganesh shankar Vidyarthi Memorial Medical College Kanpur |
| Address |
Department of Community Medicine, GSVM Medical College
Department of Community Medicine, GSVM Medical College
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
6392808729 |
| Fax |
|
| Email |
kumarvipul83746@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamlesh Chandra |
| Designation |
Junior Resident |
| Affiliation |
Ganesh shankar Vidyarthi Memorial Medical College Kanpur |
| Address |
PG HOSTEL G.S.V.M MEDICAL COLLEGE CAMPUS KANPUR UTTAR PRADESH
PG HOSTEL G.S.V.M MEDICAL COLLEGE CAMPUS KANPUR UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
6392808729 |
| Fax |
|
| Email |
kumarvipul83746@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamlesh Chandra |
| Designation |
Junior Resident |
| Affiliation |
Ganesh shankar Vidyarthi Memorial Medical College Kanpur |
| Address |
Department of Community Medicine, GSVM Medical College
Department of Community Medicine, GSVM Medical College
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
6392808729 |
| Fax |
|
| Email |
kumarvipul83746@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kamlesh Chandra |
| Address |
Department of Community Medicine, GSVM Medical College |
| Type of Sponsor |
Other [Self] |
|
|
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 Kamlesh Chandra |
Department of Neurolog LLR Hospital Kanpur |
Department of Neurology LLR Hospital Kanpur NAGAR
Kanpur Nagar
UTTAR PRADESH |
06392808729
kumarvipul83746@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSVM Medical College Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
target population of intervention |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
sleep hygiene |
Intervention group will receive sleep hygiene and the duration will be for about 12 weeks |
| Comparator Agent |
Standard care |
Patients will be receiving the standard care treatment for about 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in severity of migraine attacks measured by visual analog scale |
outcome will be assessed at baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-improvement in sleep quality measured by Pittsburg sleep quality index
2- reduction in duration of migraine attacks
3- reduction in use of analgesic medications
|
baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/05/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
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. |