NCT02847416

Brief Summary

the aim of this study are to explore the characteristics of mean airway pressure, oscillatory amplitude and power spectral density (PSD) of oscillatory airway pressure that generate by various loaded and flow rate during expiration and inspiration in healthy subjects and to explore the best loaded and flow rate for airway secretion clearance using the BreatheMAX® device

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2017

Completed
Last Updated

March 5, 2018

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

July 25, 2016

Last Update Submit

March 2, 2018

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • PSD of oscillatory airway pressure

    5 seconds during inspiration and expiration testing period

Secondary Outcomes (2)

  • mean airway pressure

    5 seconds during inspiration and expiration testing period

  • oscillatory amplitude

    5 seconds during inspiration and expiration testing period

Study Arms (2)

Inspiratory group

EXPERIMENTAL

the subjects will be instructed to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation

Device: BreatheMAX breathing device

expiratory group

EXPERIMENTAL

the subjects will be instructed to inspire as deeply as possible through the nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to 1/3 of expiratory reserve volume (ERV) for at least 3 seconds through expiratory circuit

Device: BreatheMAX breathing device

Interventions

BreatheMAX breathing deviceDEVICE
Inspiratory groupexpiratory group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the healthy subjects
  • able to breathe against resistive load with the BreatheMAX device
  • good conscious and cooperation

You may not qualify if:

  • \- fever

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Study Officials

  • sujittra Kluayhomthong, master degree

    faculty of associated medical science, KhonKaen University, Thailand 40002

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Inveatigator

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 28, 2017

Last Updated

March 5, 2018

Record last verified: 2017-08

Locations

TH(1)