Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD - a Pilot Study

NCT07292090 | Active Not Recruiting

• 1 other identifier: DNR 2025-06544-01 headache
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine and/or Cluster Headache: Study Overview \*\*Background:\*\* Migraine and cluster headache are two primary headache disorders that significantly impact quality of life and functionality in those affected. According to the WHO's recurring burden of disease reports, migraine is among the neurological conditions responsible for the highest number of years lost due to illness. The headaches associated with migraine and cluster headache range from moderate to severe and cause great suffering. Available treatments do not work for everyone and are often associated with adverse side effects. Physical activity has been shown in several studies to have a positive effect on headache. Given the high prevalence of mental health issues, stress, and sleep problems within this patient group, relaxation and low-intensity exercise such as yoga-based movements (YB) could potentially help individuals improve sleep and well-being, while also providing some preventive effect on headaches. \*\*Hypothesis:\*\* Individuals with severe migraine or cluster headache have a strong need for new treatment options. Alternative therapies such as yoga-based exercises, when combined with standard medical treatment as per clinical guidelines, may positively impact:

1. 1.Headache symptoms and frequency
2. 2.Sleep quality
3. 3.Overall life quality

Conditions

Migraine Headache; Migraine in Adults; Migraine Disorder; Migraine Headache, With or Without Aura; Migraine Headaches; Cluster Headache - Episodic and Chronic; Cluster Headaches and Other Trigeminal Autonomic Cephalgias

Keywords

yogabased exercises; body-awareness exercises; breathing exercises; tele-health; webb based intervention

Outcome Measures

Primary Outcomes (1)

• Headache diary - frequency, intensity and duration

  Headache frequency (number of days a month and number of attacks per day), headache intensity/pain using a VAS-scale, head ache duration (number of hours/minutes during an attack).

  Baseline and after the 8-12 weeks after the intervention and follow-up after 3 and 6 months

Secondary Outcomes (8)

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and after intervention of 8-12 weeks and follow-up after 3 and 6 months

• Dysfunctional Beliefs and attitudes about sleep (DBAS-10)

  Baseline and after 8-12 weeks of intervention and follow-up after 3 and 6 months

• Karolinska Sleep questionnarie (KSQ) - subjective sleepiness

  Baseline and 8-12 after the intervention as well as follow-up 3 months and 6 months

• Sleep quality using insomnia severity scale (ISI)

  Baseline and 8-12 weeks after the intervention, follow up after 3 and 6 months

• Perceived stress scale (PSS-10)

  Baseline and after 8-12 week intervention, follow-up after 3 and 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Yogabased movements weekly (online live or face to face) for primary headaches

Other: Intervention yogabased movements

Interventions

Intervention yogabased movements OTHER

Yogabased movements weekly (online) or face to face for primary headaches"

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed chronic migraine and/or cluster (Hortons) headache
• Men and women 18-65 years
• Diagnosed with chronic/high frequency migraine (≥15 headache days/month with at least ≥8 with migraine)
• Diagnosed with chronic cluster head ache (i.e shorter remission than 3 months per year), diagnosed according to ICHD-III criteria.
• Ability to perform yoga based moments and to give consent.
• Internet connection with computer/ipad/mobile to perform digitally/tele-health instructions

You may not qualify if:

• Recent or planned operations during the last 6 weeks
• Drug dependence, alcohol dependence, mental disorders as psychosis, bipolar disorder, anxiety as PTSD etc)
• Parallel enrollment in other clinical trails
• Unmedicated high blood pressure, heart disease as heart failure
• Non Swedish speaking
• Not able to perform low intensity exercise at home or FTF (face to face) - both online or live.
• Participants unsure to participate due to drug addiction or other causes
• Disorientation and not able to inform regarding other serious conditions

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Huddinge, 141 83, Sweden

Location

MeSH Terms

Conditions

Cluster Headache; Bronchiolitis Obliterans Syndrome; Migraine Disorders

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

SE (1)