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NCT Number: NCT07348783

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

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.

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Key information

Conditions

Cluster Headache - Episodic and Chronic Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Cluster Headache Cluster Headaches and Other Trigeminal Autonomic Cephalgias Graft vs Host Disease Headache Disorders Headache Disorders, Primary Immune System Diseases Lung Diseases Lung Diseases, Obstructive Migraine Disorder Migraine Disorders Migraine Headache Migraine Headache, With or Without Aura Migraine in Adults Nervous System Diseases Organizing Pneumonia Respiratory Tract Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Huddinge, 141 83, Sweden

Location status: Recruiting

Location contact

Marian E Papp, PhD - post-doc

CONTACT

[email protected]

0706946553

Marian E Papp, PhD, post-doc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention yoga based exercises

Other

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

Primary outcomes

Headache diary - frequency of headaches

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 frequency (number of days a month and number of attacks per day)

Secondary outcomes

Actrigraph - sleep quality

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

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

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

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

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

Total score between 36-78, low scores indicates high quality of life
Hospital Anxiety and Depression Scale (HADS)

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

Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire designed to assess anxiety and depression levels in individuals, particularly in non-psychiatric hospital settings. Structure: The questionnaire consists of 14 items, divided into two subscales: HADS-A for anxiety and HADS-D for depression. HADS uses a 4-point Likert scale (0 = not at all, 3 = most of the time), with separate scores for anxiety and depression subscales (0-21 each). Total scores range from 0 to 42, with higher scores indicating greater symptom severity. Cut-off scores for interpretation include:

0-7: Normal. 8-10: Mild. 11-21: Moderate to severe.
Sleep quality using insomnia severity scale (ISI)

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

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
Perceived stress scale (PSS-10)

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 interpretation of perceived stress scale (PSS-10) scores is not diagnostic but provides a general sense of of perceived stress. Generally, a score between 0-13 is considered low stress, 14-26 is moderate stress, and 27-40 is high stress.
Generalized Anxiety Disorder scale (GAD-7)

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 generalized anxiety disorder scale (GAD-7) score helps assess the severity of anxiety symptoms, with scores ranging from 0 to 21 indicating varying levels of anxiety severity.

0 - 4: No to Minimal Symptoms - Indicates little to no anxiety symptoms. 5 - 9: Mild Symptoms - Suggests mild anxiety that may not significantly impact daily functioning.

10 - 14: Moderate Symptoms - Indicates moderate anxiety, which may affect daily activities and quality of life.

15 - 21: Severe Symptoms - Reflects severe anxiety that likely requires clinical intervention and support.

Clinical Relevance A score of 10 or higher may indicate a preliminary diagnosis of Generalized Anxiety Disorder (GAD).
Nijmegen Dysfunctional breathing scale

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 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
Headache diary - intensity of headaches

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 intensity/pain using a visual analog scale (VAS-scale) where 0 is no pain and 100 is maximal pain.
Headache diary - duration of headaches

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 duration (number of hours/minutes during an attack).

Study contacts

Contact information is provided by the study sponsor or research team.

Marian E Papp, PhD

CONTACT

[email protected]

+46706946553

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Yogabased Movements Weekly (Online Live or Face to Face) for Primary Headaches

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 16, 2026
Registry last updated: Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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