Cluster Headache - Episodic and ChronicNCT07348783
Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD
A study testing Intervention yoga based exercises in people with Cluster Headache - Episodic and Chronic and Migraine Headache, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache - Episodic and Chronic, Migraine Headache, Migraine Headache, With or Without Aura
- What is being tested?
- Intervention yoga based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2026to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willing to use wristwatch for actigraphy
- Willing to leave blood samples in laboratory
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Huddinge, 141 83
Marian E Papp, PhD - post-doc, 0706946553, marian.papp@ki.se
Marian E Papp, PhD, post-doc
About this study
Official title: Yogabased Movements Weekly (Online Live or Face to Face) for Primary Headaches
Brief Summary:
Migraine and/or Cluster Headache: Study Overview
Read more
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
- Purpose and Goals:** This randomized controlled study aims to evaluate the effect of a web-based yoga (YB) or live face to face (FTF) intervention in individuals suffering of primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related changes in headache frequency, intensity, and duration associated with primary headache conditions, with a focus headache frequency. A secondary objective is to analyze quality of life, sleep quality, mental health as depression and anxiety. The RCT will also measure objective sleep and biomarkers. We are now summarizing the effects after a pilot study.
- Relevance for the Patient Group:** The core objective of the project is to determine whether yoga-based exercises can serve as a complementary treatment to enhance quality of life and health in patients with severe primary headache. To ensure equal healthcare access, this intervention will be delivered in digital format and/or FTF to optimize availability and expand care for individuals with primary headache disorders. These efforts aim to improve life quality and well-being in a vulnerable patient population. Headache conditions often affect individuals in their most productive years, and many live with symptoms for decades. Both work and private life are frequently disrupted, resulting in sick leave and social isolation. Close relatives are also affected, as those suffering from headaches require more recovery time to cope with daily life. With this proposed project, we aim to use physical yoga, rooted in holistic traditional medicine, to help individuals with severe primary headache achieve better physical and mental health-particularly improved sleep quality, which in turn enhances overall life quality.
Read the detailed description
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.
- Conditions
- Cluster Headache - Episodic and Chronic, Migraine Headache, Migraine Headache, With or Without Aura, Migraine in Adults, Cluster Headaches and Other Trigeminal Autonomic Cephalgias, Migraine Disorder
- Being tested
- Intervention yoga based exercises
- Medical subject headings
- Cluster Headache, Bronchiolitis Obliterans Syndrome, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention yoga based exercisesOther
8-12 weeks intervention using digital och face to face yogic exercises
| Study group | Role | What they receive |
|---|---|---|
| Intervention yogic exercises | Experimental | Yogabased movements (online live or face to face) for primary headaches Receives: Other: Intervention yoga based exercises |
| No intervention - waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache diary - frequency of headaches
Headache frequency (number of days a month and number of attacks per day)
Measured: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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)
Measured: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 May 2026
- Primary completionDec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster Headache - Episodic and ChronicStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Papp, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348783
- Sponsor's protocol ID
- DNR 2025-06544-0 RCT study
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No