RECRUITING

High Dose Inspiratory Muscle Training in LOPD

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Conditions

Late-Onset Pompe DiseaseLysosomal DiseaseLOPD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study Objectives: 1) assess the safety and feasibility of high-dose inspiratory muscle training (IMT) delivered remotely in Late-onset Pompe Disease (LOPD) and 2) determine its effects on respiratory and patient-reported outcomes.

Official Title

High-dose Inspiratory Muscle Training (IMT) in Late-onset Pompe Disease (LOPD)

Quick Facts

Study Start:2022-07-19
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05431127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Confirmed diagnosis of LOPD
  3. * MIP \>50% of predicted for sex and age
  4. * Stable on current Pompe disease treatment regimen \>6 months
  5. * Able to follow directions for study participation
  6. * Access to computer and smartphone/tablet with reliable internet connection for video visits and sensor-based respiratory technologies
  1. * Presence of medical comorbidities that prevent meaningful study participation (e.g., COPD GOLD III-IV, significant mental illness, dementia)
  2. * Use of continuous invasive or non-invasive ventilation while awake
  3. * Prior history of gene therapy for LOPD
  4. * Inability to give legally effective consent
  5. * Inability to read and understand English

Contacts and Locations

Study Contact

Kelly Crisp, MA, CCC-SLP
CONTACT
919-681-1852
kelly.crisp@duke.edu
Maria Manson
CONTACT
919-681-4595
maria.manson@duke.edu

Principal Investigator

Harrison Jones, PhD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Harrison Jones, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-19
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2022-07-19
Study Completion Date2025-03-01

Terms related to this study

Keywords Provided by Researchers

  • LOPD

Additional Relevant MeSH Terms

  • Late-Onset Pompe Disease
  • Lysosomal Disease