- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19129
- HGE Health Care Solutions
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Correlation of Respiration Rate to Indicators of Healthcare Utilization
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
Lasso di tempo: 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
Lasso di tempo: 12 weeks
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12 weeks
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Correlation of Respiration Rate to COPD Episode Duration
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gerard Criner, MD, Temple University
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MA-16-05-01
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .