NCT04776122

Brief Summary

The study will examine the usability of a breathing platform in the home environment. It will be a randomized, open-label crossover study of 10 participants who will complete the CBT and breathing components in their home, prior to sleeping. Usability will be measured by scores assigned by participants. Qualitative feedback and compliance information will also be collected.

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 Jun 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

29 days

First QC Date

April 6, 2020

Last Update Submit

February 25, 2021

Conditions

Breathing, Mouth

Outcome Measures

Primary Outcomes (1)

  • Ease of use

    Participants will complete a questionnaire rating how easy it was to use and sleep with the device providing assistance to their breathing patterns

    8 days

Secondary Outcomes (1)

  • Compliance

    8 days

Study Arms (2)

Control with no device

ACTIVE COMPARATOR

Breathing performed with no device

Other: No device

Therapy - device assisted breathing

EXPERIMENTAL

Breathing performed with device

Device: Therapy

Interventions

TherapyDEVICE

Device-assisted breathing for relaxation

Therapy - device assisted breathing
No deviceOTHER

Breathing platform without device

Control with no device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants are willing to give written, informed consent
  • Participants are healthy adults
  • Participants are able to comprehend and speak English
  • Participants are at least 18 years of age

You may not qualify if:

  • Participants who are/may be pregnant or lactating
  • Participant that have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ResMed Ltd

Sydney, Australia

Location

MeSH Terms

Conditions

Mouth Breathing

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeff Armitstead

    ResMed

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

March 1, 2021

Study Start

June 1, 2018

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)