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

NCT07292090 | Recruiting

• 1 other identifier: DNR 2025-06544-01 headache
• Study Type: interventional
• Target: 40
• 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
2. 2.Sleep quality
3. 3.Overall life quality

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Sleep quality using insomnia severity scale (ISI)

  Total score from 0-28 - a score of 0-7 no clinical insomnia, 8-14 no insomnia, 15-21 clinical insomnia moderate, 22-28 clinical insomnia severe

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

• Quality of life - headache intensity scale (HIT-6)

  Total score between 36-78, low scores indicates high quality of life

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

• Karolinska Sleep questionnarie (KSQ) - subjective sleepiness

  KSQ includes 18 questions - on a 6 graded likert scale between 0-5, where 0 = never and 5 = always. Higher scores means more sleep problems. Each domain is calculated with a mean, sleep quality 4 questions, problem waking 3 questions, sleep apnea (breath pause - andningsuppehåll) - 3 questions, sleepiness/tiredness - 6 questions. One is not using total scores for the KSQ. It is also possible to calculate index-value for insomnia and sleep apnea. There are cut-off values to compare with a healthy population or other studies with the same disorder. There are cut-offs for KSQ for normal swedish population but also using the 90:e percentile for a swedish population (different for men and women)

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

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

  Measures sleep related cognitions in a VAS-scale. The scale identifies specific, irrationell and affective thoughts that can disturb insomnia and evaluated sleep related cognitions. Factor I (5 items) was labeled Beliefs about the Immediate Negative Consequences of Insomnia. Factor II (3 items) was labeled Beliefs about the Long-term Negative Consequences on Insomnia. Factor III was labeled Beliefs about the Need for Control Over Insomnia (2 items). Administration time 10 minutes

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

Secondary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and after intervention of 8-12 weeks and 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

• Generalized Anxiety Disorder scale (GAD-7)

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

• Headache diary - frequency, intensity and duration

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

• Nijmegen Dysfunctional breathing scale

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

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

RECRUITING

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

Central Study Contacts

Marian Papp, PhD

CONTACT

+46706946553; marian.papp@ki.se

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: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-10

Locations

SE (1)