Actigraphy and Nocturnal Heartrate Variability in Cluster Headache Patients

NCT03010189 | Completed

• 1 other identifier: 2015/1789(REK)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cluster headache; Actigraphy; Pupillometry

Outcome Measures

Primary Outcomes (5)

• Change in pupillary average contraction velocity

  The velocity of pupillary constriction in response to light, measured with a pupillometer, in mm/sec

  Once in the beginning of a headache phase, and once 4 weeks after last headache attack

• Change in total sleep time

  Average number of hours asleep per night, measured over two weeks with an actigraph

  Measured for two weeks during headache phase, and again four weeks after last headache attack

• Change in sleep efficiency

  Average number of hours asleep per night divided by time spent in bed, measured over two weeks with an actigraph

  Measured for two weeks during headache phase, and again four weeks after last headache attack

• Change in wake after sleep onset

  Average number of awakenings during the sleep phase, measured over two weeks with an actigraph

  Measured for two weeks during headache phase, and again four weeks after last headache attack

• Change in LF/HF ratio

  The ratio of low-frequency and high-frequency fluctuations in heart rate, measured over two weeks with a heart-rate variability monitor

  Measured for two weeks during headache phase, and again four weeks after last headache attack

Study Arms (2)

Patient

EXPERIMENTAL

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; Device: Heart-rate variability monitoring; Device: Pupillometry

Controls

ACTIVE COMPARATOR

Healthy controls undergo the same examinations once: light reflex pupillometry, actigraphy and heart-rate variability monitoring.

Device: Actigraphy; Device: Heart-rate variability monitoring; Device: Pupillometry

Interventions

Actigraphy DEVICE

A small computer in the shape of a wristwatch, that registers movement and assesses sleep quality.

Controls; Patient

Heart-rate variability monitoring DEVICE

A small computer that registers variation in heart rate, which reflects cardiac autonomic tone.

Controls; Patient

Pupillometry DEVICE

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.

Controls; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cardiac arrythmia or known autonomic dysfunction.

Sponsors & Collaborators

• Nordlandssykehuset HF: lead
• University of Tromso: collaborator

Study Sites (1)

Nordland Hospital Trust

Bodø, Nordland, 8003, Norway

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Karl B Alstadhaug, MD, PhD

  Nordlandssykehuset HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: January 4, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)