- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03030313
Respiration Rate Monitoring in COPD Patients
Assessment of the Temporal Changes in Nightly Respiration Rate in Combination With a Daily Symptom Reporting Application for Facilitating Early Treatment of Symptoms in COPD Patients
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The research question is whether monitoring of respiration rates and variability can be helpful in management of COPD patients in conjunction with or separately from self-reported symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's self-reported symptoms) have limited sensitivity and specificity with regard to predicting decompensation. Measurement of respiration parameters and the variability of the parameters may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in advance of decompensation (e.g. >5 days prior to patient symptoms) such that it would allow an opportunity for earlier intervention with medical assessment and current therapeutic approaches.
The specific primary aim includes evaluation of the correlation of respiration rate parameters to indicators of healthcare utilization including drug changes, office or ER visits, hospitalization, or other clinical interventions. Secondary aims include evaluation of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict COPD worsening requiring medical intervention, and the correlation of respiration rate parameters to episode duration as defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19129
- HGE Health Care Solutions
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Males or females age ≥35 years old
- Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
- Weight ≥35 kg
- Currently using the COPD Co-PILOT application (at least 3 months with 70% compliance)
- Must be able to read and understand English and consent for themselves
Exclusion Criteria:
- Currently using any form of non-invasive positive airway pressure ventilation
- Diagnosis of significant heart failure (NYHA Class III or IV)
- Cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
- BMI ≥45.5
- Residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
- Currently using a wearable drug infusion pump to deliver medication
- Planned procedures at time of enrollment that will occur within timeframe of study and require hospitalization etc.
- Declines to participate at any time.
- In the opinion of the Investigator, may be non-compliant with study schedules or procedures
- No cellular coverage at their primary residence
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Respiration rate monitoring
Reassure Non-Contact Respiration Monitor
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Reassure Respiration Monitor uses very low power radio waves to detect respiratory movements of a person while asleep in bed - without physical contact with the individual.
Algorithms analyze the respiratory movement signals and extract information about respiration rate and variability.
This data is uploaded to a secure cloud infrastructure for storage.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Correlation of Respiration Rate to Indicators of Healthcare Utilization
Zeitfenster: 12 weeks
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Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.
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12 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
Zeitfenster: Baseline to 12 weeks
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Baseline to 12 weeks
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Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening
Zeitfenster: 12 weeks
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12 weeks
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Correlation of Respiration Rate to COPD Episode Duration
Zeitfenster: 12 weeks
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Episode duration is defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days)
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12 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Gerard Criner, MD, Temple University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MA-16-05-01
Plan für individuelle Teilnehmerdaten (IPD)
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