Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04624191
Study type	Interventional
Source	Laval University
Contact	Geneviève Dion
Phone	418-656-8711
Email	geneviève.dion@criucpq.ulaval.ca
Status	Recruiting
Phase	N/A
Start date	November 11, 2020
Completion date	June 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME) — SATURHOME

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms