ClinicalTrials.gg
Status unknownNCT03368612AirGoTMUpdated Dec 11, 2017

Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function

An observational study in Respiration Disorders, sponsored by Ospedale Santa Croce-Carle Cuneo. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-11.

Sponsored by Ospedale Santa Croce-Carle Cuneo · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Respiration Disorders with a site in Italy — 3 open to participants now, 4 under way, none of them phase 3. Respiration Disorders · Italy.

Planned enrollment
8th of 10
100 · median 563
Started
2017
with 1 other
Observational
10 of 18
1 open now
Registered
6th of 18
by date

Among the 18 studies in Respiration Disorders with a site in Italy, this one is the 8th largest by planned enrollment of the 10 observational ones that give a count, is one of 2 that started in 2017, is one of 10 observational ones, and was the 6th registered.

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

Browse Respiration Disorders studies →

Open to participants now

3 of the 18 studies in Respiration Disorders with a site in Italy are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.

Read the detailed description

Primary endpoint:

  • To test the AirGoTM system's respiratory rate recording accuracy at rest and during physical exercise, as compared to standard tests.

Secondary endpoints:

  • To test the accuracy of the AirGoTM system's derived respiratory parameters (tidal volume, minute ventilation, Tiffeneau-Pinelli index, FEV1 and VO2max) at rest and during physical exercise, as compared to standard tests.
  • To test comfort and subjects' compliance with the AirGoTM system during long term recording (24 hours).
03

Conditions studied

  • Respiration Disorders

Browse trials for

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy volunteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-smoker healthy volunteers,
  • Able to perform a routine respiratory function test (spirometry and cardiopulmonary exercise testing),
  • aged between 18 and 75 years,
  • who signed a written .

Exclusion criteria

Exclusion Criteria:

  • Present cardiac comorbidities (eg. coronary artery disease, heart failure, arrhythmias);
  • History of coronary artery disease or heart failure;
  • Respiratory comorbidities (eg. asthma, chronic obstructive disease, sleep apnoea, lung interstitial disease);
  • Pregnancy;
  • Former smoker of >5 p/y;
  • Severe trauma or major surgery in the last year;
  • Chest pain;
  • Obesity ( >30).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherElectronic evaluation system

    spirometry, plethysmography, cardiopulmonary exercise test

  • OtherElectronic evaluation system

    AirGo recording

    Also known as: AirGoTM System

06

What researchers measure

Primary outcomes

  1. respiratory rate

    number of respiratory cycles completed in one minute

    Time frame: 4 minutes

Secondary outcomes

  1. tidal volume

    volume of air moved during a single respiratory cycle (inspiration and expiration) during normal breathing (in ml)

    Time frame: 4 minutes

07

Study locations

1 of 1 sites recruiting
  • A.O. S. Croce E Carle Di Cuneo
    Cuneo, 12100, Italy
    Recruiting
    • FRANCESCO GIURLANDA · ContactTRIALS@OSPEDALE.CUNEO.IT · +39017161
    • ANDREA ANTONELLI, MD · Principal investigator
    • ALESSIA STANZI, MD · Sub investigator
    • PAOLO NOCETI, MD · Sub investigator
    • FEDERICO MAZZA, MD · Sub investigator
    • GIULIO MELLONI, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Sep 2019, 24 months after the start.

Of 60 non-industry observational studies under Respiration Disorders, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 24 months is below that.

Counting every sponsor, half of 75 studies reached it within 26 months; a quarter within 10 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2017
First posted
Dec 11, 2017
StartActual
Sep 22, 2017
Primary completionEst.
Sep 22, 2019
CompletionEst.
Sep 22, 2019
Last update
Dec 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03368612
Lead sponsor
Ospedale Santa Croce-Carle Cuneo
Responsible party
Andrea Antonelli (Principal Investigator, MD, Ospedale Santa Croce-Carle Cuneo) — Principal investigator
First posted
Dec 11, 2017
Start date
Sep 22, 2017
Primary completion
Sep 22, 2019 (estimated)
Completion
Sep 22, 2019 (estimated)
Last update
Dec 11, 2017

Study contacts

ANDREA ANTONELLI, MD
Contact
ANTONELLI.A@OSPEDALE.CUNEO.IT
+39017161 ext. 6794
ALESSIA STANZI, MD
Contact
STANZI.A@OSPEDALE.CUNEO.IT
+39017161 ext. 6738

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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