Actigraphy and Nocturnal Heartrate Variability in Cluster Headache Patients

NCT03010189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-03-21

No results posted yet for this study

Summary

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.

Conditions

  • Cluster Headache
  • Sleep

Interventions

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.

Sponsors & Collaborators

  • University of Tromso

    collaborator OTHER
  • Nordlandssykehuset HF

    lead OTHER

Principal Investigators

  • Karl B Alstadhaug, MD, PhD · Nordlandssykehuset HF

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010189 on ClinicalTrials.gov