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Actigraphy and Nocturnal Heartrate Variability in Cluster Headache Patients

This study is currently recruiting participants.
Verified March 2017 by Nordlandssykehuset HF
Sponsor:
ClinicalTrials.gov Identifier:
NCT03010189
First Posted: January 4, 2017
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Nordlandssykehuset HF
  Purpose

Cluster headache is one of the most painful headaches, characterized by recurring episodes of unilateral, periorbital pain, which is accompanied by autonomic symptoms that seem to be of both sympathetic and parasympathetic origin. The pathophysiology behind the condition is largely unknown, but increasing evidence indicate that the hypothalamus plays a pivotal role. The headache attacks come in clusters or bouts (hence the name) which last up to three months, after which the headache disappears for at least one month. 10-15% have chronic cluster headache. During attacks, the patients have cranial sympathetic hypoactivity and parasympathetic hyperactivity, whereas they have cranial parasympathetic hypoactivity during remission phase. There is an emerging hypothesis that headache attacks are elicited in a state of autonomic hypoarousability, which is also supported by the fact that most cluster attacks occur during the night, when the patients are sleeping.

The aim in this project is to study the intercept between the sleep-wake cycle, autonomic tone and the occurrence of headache attacks, by using actigraphy, heart-rate variability and pupillometry. All these methods are well validated, and frequently used in studies on sleep and autonomic function. The study design is that of a case-control model where 15 cluster headache patients will undergo pupillometry, before wearing the actigraph and heart-rate variability-monitor for two weeks, once in cluster bout and once in remission phase. The actigraphy will register nocturnal movement and sleep quality, and headache attacks will be registered by pressing a button on the actigraph. The pupillometry measures pupillary constriction and dilation in response to light, a reflex that is controlled by the autonomic nervous system. The heart-rate variability monitors fluctuations in the heart rate which reflects the sympathovagal balance of cardiac control. All participants will fill out the Pittsburgh Sleep Quality Index before and after registration. In addition, 15 healthy controls will undergo one session of the same examinations. The results of the study will give valuable insight to the pathophysiology of a condition that is very painful and has great impact on the patients' quality of life, and also add knowledge to the relation between headache, sleep and the autonomic nervous system.


Condition Intervention
Cluster Headache Sleep Device: Actigraphy Device: Heart-rate variability monitoring Device: Pupillometry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Actigraphy and Nocturnal Heartrate Variability in Cluster Headache Patients

Resource links provided by NLM:


Further study details as provided by Nordlandssykehuset HF:

Primary Outcome Measures:
  • Change in pupillary average contraction velocity [ Time Frame: Once in the beginning of a headache phase, and once 4 weeks after last headache attack ]
    The velocity of pupillary constriction in response to light, measured with a pupillometer, in mm/sec

  • Change in total sleep time [ Time Frame: Measured for two weeks during headache phase, and again four weeks after last headache attack ]
    Average number of hours asleep per night, measured over two weeks with an actigraph

  • Change in sleep efficiency [ Time Frame: Measured for two weeks during headache phase, and again four weeks after last headache attack ]
    Average number of hours asleep per night divided by time spent in bed, measured over two weeks with an actigraph

  • Change in wake after sleep onset [ Time Frame: Measured for two weeks during headache phase, and again four weeks after last headache attack ]
    Average number of awakenings during the sleep phase, measured over two weeks with an actigraph

  • Change in LF/HF ratio [ Time Frame: Measured for two weeks during headache phase, and again four weeks after last headache attack ]
    The ratio of low-frequency and high-frequency fluctuations in heart rate, measured over two weeks with a heart-rate variability monitor


Estimated Enrollment: 30
Study Start Date: January 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient
Cluster headache patients are examined with light reflex pupillometry, two weeks actigraphy and heart-rate variability monitoring both in headache phase and remission phase.
Device: Actigraphy
A small computer in the shape of a wristwatch, that registers movement and assesses sleep quality.
Device: Heart-rate variability monitoring
A small computer that registers variation in heart rate, which reflects cardiac autonomic tone.
Device: Pupillometry
A handheld infrared camera that sends out a light flash and records the pupil as it contracts and dilates, as a measure of pupillary autonomic tone.
Active Comparator: Controls
Healthy controls undergo the same examinations once: light reflex pupillometry, actigraphy and heart-rate variability monitoring.
Device: Actigraphy
A small computer in the shape of a wristwatch, that registers movement and assesses sleep quality.
Device: Heart-rate variability monitoring
A small computer that registers variation in heart rate, which reflects cardiac autonomic tone.
Device: Pupillometry
A handheld infrared camera that sends out a light flash and records the pupil as it contracts and dilates, as a measure of pupillary autonomic tone.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Episodic or chronic cluster headache, according to the ICHD-IIIb criteria.

Exclusion Criteria:

  • Cardiac arrythmia or known autonomic dysfunction.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010189


Contacts
Contact: Hilde K Ofte, MD +4790644756 hkofte@gmail.com
Contact: Petter R Øien +4775344000 petter.roman.oien@nlsh.no

Locations
Norway
Nordland Hospital Trust Recruiting
Bodo, Nordland, Norway, 8003
Contact: Hilde K Ofte, PhD    90644756    hkofte@gmail.com   
Sponsors and Collaborators
Nordlandssykehuset HF
University of Tromso
Investigators
Principal Investigator: Karl B Alstadhaug, MD, PhD Nordlandssykehuset HF
  More Information

Responsible Party: Nordlandssykehuset HF
ClinicalTrials.gov Identifier: NCT03010189     History of Changes
Other Study ID Numbers: 2015/1789(REK)
First Submitted: July 27, 2016
First Posted: January 4, 2017
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nordlandssykehuset HF:
Cluster headache
Actigraphy
Pupillometry

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases