An interventional study of Intervention yoga based exercises in Cluster Headache - Episodic and Chronic, Migraine Headache and Migraine Headache, With or Without Aura, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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:
Headache symptoms, Sleep quality and Overall life quality
Detailed Description:
Current Situation
Migraine and cluster headache are two neurological conditions characterized by recurrent attacks of severe headache. Approximately 14% of the population is estimated to suffer from migraines, while cluster headaches have a prevalence of around 0.1%. The phenotype is marked by unilateral headache attacks lasting approximately 15 minutes to three hours for cluster headache and three hours to three days for migraine. Acute treatment for migraines and cluster headaches typically involves triptans or oxygen therapy to break the attacks, and prophylactic treatment when needed.
Studies have shown that individuals with headaches experience significant impacts on quality of life and often suffer from mental health issues. Research from Karolinska Institutet and the Headache Centre in Copenhagen has demonstrated sleep disturbances among individuals with cluster headaches. Sleep-related diagnoses are also frequently reported in individuals with migraine, and migraine is more prevalent among shift workers compared to non-shift workers. Collectively, these studies indicate a strong connection between sleep problems, mental health, and headache.
The disease burden in high-frequency migraine, chronic migraine, and cluster headache is substantial, and additional alternative treatments are needed alongside standard pharmaceutical therapies. Individuals with these headache types report higher sick leave rates than the general population, and cluster headache sufferers with concurrent mental health issues show increased prevalence for long-term sick leave and disability pension.
Role of Yoga-Based Exercises (YB)
Yoga-based exercises have gained attention in healthcare and are used as complementary treatments for various conditions. Reviews and meta-analyses show effects on stress symptoms, mental states such as sleep disturbances and depression. Web-based yoga interventions have also improved sleep and stress, as well as chronic neck and back pain. Improvements have been observed in endothelial function and inflammation markers.
A review article from China indicates that physical yoga (similar to the planned intervention) appears to reduce headache intensity, duration, and frequency. Previous studies show reductions in migraine headache following yoga interventions, and smaller Indian studies report effects on headache intensity and quality of life in migraine. Research in Western contexts is limited and studies conducted in India tend to show more positive results-possibly due to higher treatment dosages or contextual influences, including placebo or Hawthorne effects.
The American Migraine Foundation recommends yoga-based exercises as a complementary treatment for stress reduction and migraine symptom management, as stress is a common migraine trigger. There is currently no research on yoga-based interventions for cluster headaches, and only a few published studies on migraines.
Traditional Medical Practices
Indian traditional medicine recommends specific exercises (e.g., inversions) for treating headaches, high blood pressure, and improving sleep quality and insomnia. Inversions appear to activate deep brain regions related to sleep and have a calming effect. Sleep disorders often trigger migraines and vice versa. Melatonin rhythms, which may be unstable in headache conditions, often stabilize following yoga-based interventions.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 80 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
Yogabased movements (online live or face to face) for primary headaches
Other: Intervention yoga based exercises
8-12 weeks intervention using digital och face to face yogic exercises
Headache diary - frequency of headaches
Headache frequency (number of days a month and number of attacks per day)
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Headache diary - intensity of headaches
Headache intensity/pain using a visual analog scale (VAS-scale) where 0 is no pain and 100 is maximal pain.
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Actrigraph - sleep quality and activity level
Objective measurement of sleep using actigraphs worn on the wrist for one week at baseline and one week at the end of the study. ActTrust 2, Actiwatch or another brand is a wristwatch-like device that measures acceleration. By measuring acceleration at the wrist, an estimate of physical activity can be obtained, from which an activity pattern for a participant can be produced. This provides an objective measure of sleep duration and sleep quality. The sleep watch measures activity in general using tri-axial raw data accelerometer along with environmental light and temperature sensors and sleep is part of this through looking at reduced activity.
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Dysfunctional Beliefs and attitudes about sleep (DBAS-10)
Measures sleep related cognitions in a VAS (visual analog)-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). People with insomnia have higher DBAS scores than good sleepers. Administration time 10 minutes
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Perceived stress Questionnaire (PSQ-30)
PSQ includes 30 questions and measures stress symptoms in adults. It includes a Likertscale with 4 options. Where 1= almost never; 2= sometimes;3=oftan;4=most of the time Scoring Total score = summary of all items Reversed scoring for questions: 1, 7, 10, 13, 17, 21, 25, 29 PSQ Index (totalscore-30)/90 https://onlinelibrary.wiley.com/doi/abs/10.1002/smi.946
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Nijmegen Dysfunctional breathing scale
The Nijmegen Questionnaire (often called the Nijmegen Dysfunctional Breathing Scale) is a validated screening tool designed to identify symptoms of dysfunctional breathing, particularly hyperventilation/overbreathing syndrome. It consists of 16 symptom items scored on a 0-4 scale, with higher scores indicating greater respiratory distress. A total score above 19-23 suggests clinically relevant breathing dysfunction. 16 items covering common symptoms such as chest pain, dizziness, blurred vision, shortness of breath, and feelings of tension. Each item is rated on a 5-point Likert scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Very often. 19 points: Indicates possible dysfunctional breathing or hyperventilation. 23 points: Stronger indication of hyperventilation syndrome
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Neck-pain - number of days a month
Number of neck-pain days month (number of days with neck-pain).
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
The Migraine Disability Assessment Test (MIDAS)
MIDAS measures measure the impact the headaches have on quality of life 0-5 points - Grade 1=Little or No Disability, 6-10 points - Grade 2=mild disability, 11-20 points - Grade 3= moderate disability, 21+ points - Grade 4 = severy disability If MIDAS Score is 6 or more contact with doctor i suggested https://headaches.org/wp-content/uploads/midas.pdf
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Intensity of neck-pain
One single question of the intensity of neck-pain intensity/pain using a visual analog scale (VAS-scale) where 0 is no pain and 10 is maximal pain.
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
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. Some reversed scoring. One is not using total scores for the KSQ. It is also possible to calculate index-values. 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)
Time frame: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.
Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's planned 19 months is close to that.
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