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

NCT07348783 | Not Yet Recruiting

• 1 other identifier: DNR 2025-06544-0 RCT study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 quality of life, with a focus on sleep quality and mental health as depression and anxiety. A secondary objective is to analyze changes in headache frequency, intensity, and duration associated with primary headache conditions. The RCT will also measure objective sleep and biomarkers. We are now investigating 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.

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

Outcome Measures

Primary Outcomes (4)

• Sleep quality using insomnia severity scale (ISI)

  Primary Outcome Measure: Sleep quality using insomnia severity scale (ISI) \[Time Frame: Baseline and 8-12 weeks after the end of the intervention, follow-up up to 24 weeks\] 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 (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks

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

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

  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). Administration time 10 minutes

  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

  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.

  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 (13)

• Hospital Anxiety and Depression Scale (HADS)

  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 scale (PSS-10)

  Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks

• Generalized Anxiety Disorder scale (GAD-7)

  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

  Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks

• Interleukine 6 (IL-6)

  Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks

Study Arms (2)

Intervention yogic exercises

EXPERIMENTAL

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

Other: Intervention yoga based exercises

No intervention - waiting list

NO INTERVENTION

Interventions

Intervention yoga based exercises OTHER

8-12 weeks intervention using digital och face to face yogic exercises

Intervention yogic exercises

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
• Willing to use wristwatch for actigraphy
• Willing to leave blood samples in laboratory

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

Central Study Contacts

Marian E Papp, PhD

CONTACT

+46706946553; marian.papp@ki.se

Study Design

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

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

SE (1)