Vagal Nerve Stimulation Assessed by the Diving Reflex: An Investigation Into Mechanisms of Asthma Death

Last updated: March 10, 2014
Sponsor: Hull University Teaching Hospitals NHS Trust
Overall Status: Completed

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Asthma

Dizzy/fainting Spells

Treatment

N/A

Clinical Study ID

NCT02083029
CTU070813
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The investigators' hypothesis is that dysregulation of autonomic function, as revealed during a simulated dive reflex, may result in an attenuation of the heart rate response to a greater degree in asthmatics who collapse during exacerbations of asthma than that seen in healthy individuals and in asthmatics without a history of syncope. The investigators will test this by assessing autonomic function through a dive reflex protocol.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Syncopal Asthmatics: Asthmatic patients with a history of syncope during asthmaexacerbations

  • Normal Asthmatics: Asthmatic patients on BTS Step 3 treatment (LABA/ICS) with nohistory of syncope during exacerbations

  • Normal volunteers: no history of airways disease or syncope

Exclusion

Exclusion Criteria:

  • • Subjects who are pregnant, or have pacemakers in situ are excluded from this study.

  • Subjects with significant cardiovascular disease are excluded from this study.

  • Those who are non-English speakers and special groups (i.e. mentally ill,children under 16 years of age, and those suffering from dementia) will beexcluded.

  • No test will be performed on any subject during an acute worsening of asthma orupper airway infection. If the subject has had an upper airway infection in thelast three weeks. Another appointment should be made unless the subject isunwilling to come back, in which case testing should continue. The number of dayselapsed since the end of the airway infection should be recorded.

  • If the subject smokes: citric acid or capsaicin challenges must be performed atleast one hour after the last cigarette has been smoked.

  • Subjects taking beta-blockers and calcium antagonists will be excluded from thisstudy. No beta agonists should be taken within 6 hours of starting this study.

  • If the subject has taken any over the counter (OTC) cough mixture within the lasttwelve hours: If the subject is willing to come back another time for challengetesting, another appointment should be made. If the subject is unwilling toreturn another time, testing should proceed and the medication used recorded.

  • If the subject has had any food or drink products containing caffeine or mentholwithin the last hour. If the subject is unwilling to wait for 1 hour beforestarting the test, the subject should return another time. If the subject isunwilling to return another time, testing should proceed and the medication usedrecorded.

  • If the participant is currently involved in research, or within 3 months ofparticipation in any type of research, they will be excluded from this study.

Study Design

Total Participants: 24
Study Start date:
January 01, 2013
Estimated Completion Date:
January 31, 2014

Study Description

Tests of autonomic function are notoriously difficult to evaluate. Here the investigators required a well validated test of the dynamic cardiovascular response to an abrupt stimulus and considered the diving reflex the most reliable and practical. In man, the diving reflex acts as a vestigial reflex aimed at conserving oxygen storage during apnoeic facial immersion. Facial immersion activates a vagally-induced bradycardia and a sympathetically activated alpha-adrenergic peripheral vasoconstriction and hypertension. There are two triggers of the diving reflex, facial immersion in water and breath hold, both of which can impact on heart rate attenuation. Facial immersion can be further delineated into exposure to cold, wetness and pressure.

Connect with a study center

  • Hull Clinical Trials Unit, Respiratory academic department

    Cottingham, Yorkshire HU16 5JQ
    United Kingdom

    Site Not Available

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