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Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)

Study Purpose

The use of saturometry at home is more and more widespread in patients suffering from interstitial pulmonary diseases (IPD), the patients seeing it as reassurance and a concrete way to follow the evolution of their disease. However, there are no studies evaluating the real clinical benefit of taking saturation at home in this population. In addition, clinical experience seems rather to demonstrate an increase in the anxiety level and the number of clinically unnecessary consultations related to the use of this measure. The secondary objectives are to determine the impact of this measurement on:

  • (1) the health care use (telephone calls, medical consultations and hospitalizations), (2) dyspnea score, (3) the anxiety and depression score (HADS score) and (4) the physical activity level.
The exploratory objectives will be to determine if the measurement of saturation at home makes it possible to
  • (1) predict the occurrence of acute exacerbations of fibrosis, (2) effectively predict the decline in respiratory function tests and (3) 1-year mortality.
The investigator will also assess whether this measure makes it possible to screen patients with oxygen therapy needs at home. The investigator hypothesize that measuring oxygen saturation at home will lead to a significant deterioration in quality of life, an increase in the use of health care, a significant increase in the rate of anxiety and depression, dyspnea and a decrease in the physical activity level.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Fibrosing interstitial lung disease.
  • - Saturation below 90% during the 6-minute walk test.
  • - Clinically stable.

Exclusion Criteria:

- Oxygen dependent at rest

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Laval University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Geneviève Dion, MD
Principal Investigator Affiliation Institut universitaire de pneumologie et cardiologue de Québec - ULaval
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Canada

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Additional Details

Measurement tools. 1. Quality of life: King's Brief Interstitial Lung Disease. 2. Anxiety and depression score: HADS score. 3. Dyspnea score : UCSD questionnaire. 4. Physical activity level during 7 days: MoveMonitor by McRoberts. 5. Home base saturation: Nonin Ny vantagr 9590. 6. Disease evolution : complete lung function (plethymography, sprimoetry, DLCO), 6-minute walking test (following the ATS recommandation)

Arms & Interventions


Experimental: Intervention Group

Intervention group participants will be asked to measure their oxygen saturation on a daily basis.

No Intervention: Control Group

Usual Care


Other: - Saturation at home

Clinical benefit of taking saturation at home in interstitial lung disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Québec, Canada




Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, , G1V 4G5

Site Contact

Geneviève Dion, M.D. FRCPC


418-656-8711 #5511