NCT07348783 Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD
| NCT ID | NCT07348783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Cluster Headache - Episodic and Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-05-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07348783 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cluster Headache - Episodic and Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07348783 currently recruiting?
Yes, NCT07348783 is actively recruiting participants. Contact the research team at marian.papp@ki.se for enrollment information.
Where is the NCT07348783 trial being conducted?
This trial is being conducted at Huddinge, Sweden.
Who is sponsoring the NCT07348783 clinical trial?
NCT07348783 is sponsored by Karolinska Institutet. The trial plans to enroll 80 participants.