NCT03733704

Brief Summary

40 healthy volunteers underwent a trial of obstructed breathing through an eighteen cm long, four mm internal diameter tube. Heart rate was recorded during three consecutive sets comprised of one minute control followed by one minute of obstructed breathing, with one minute of rest between sets. Time and frequency domain analysis were used to compare HRV during control versus obstructed breathing.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2015

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2015

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

22 days

First QC Date

November 4, 2018

Last Update Submit

November 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Low Frequency Power Spectral Density

    FFT HRV Low Frequency Power Spectral Density

    1 minute

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Healthy volunteers

Diagnostic Test: Heart rate variability analysis

Interventions

Heart rate variability analysis extracted from ECG during normal and obstructed breathing

Healthy volunteers

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • healthy

You may not qualify if:

  • heart disease
  • lung disease
  • BMI \> 26
  • ECG abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lehavi A, Golomb N, Leiba R, Katz YS, Raz A. One-minute heart rate variability - an adjunct for airway obstruction identification. Physiol Rep. 2019 Jan;7(1):e13948. doi: 10.14814/phy2.13948.

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Spontaneous ventilation via an obstructing plastic tube
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatric Anesthesia

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 7, 2018

Study Start

May 20, 2015

Primary Completion

June 11, 2015

Study Completion

July 1, 2015

Last Updated

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share