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CompletedNCT03255213Updated Jul 28, 2021

Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)

An interventional study of Lingual Muscle Training in Glycogen Storage Disease, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Glycogen Storage Disease with a site in United States — 5 open to participants now, 6 under way, none of them phase 3. Glycogen Storage Disease · United States.

Started
2018
the only one that year
No phase
2 of 16
none open now
Registered
9th of 16
by date
Lead sponsor
3 of 16
Duke University

Among the 16 studies in Glycogen Storage Disease with a site in United States, this one is the only one that started in 2018, is one of 2 with no phase, and was the 9th registered.

Glycogen Storage Disease

36 studies on the registry are indexed under Glycogen Storage Disease; 13 are open to participants now.

Browse Glycogen Storage Disease studies →

Open to participants now

5 of the 16 studies in Glycogen Storage Disease with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 9 Glycogen Storage Disease studies recruiting now, 4 set no upper age limit and 4 stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.

This study: 12 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help design future research studies about LMT in LOPD.

03

Conditions studied

  • Glycogen Storage Disease
04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 12 years
  • Lingual weakness as measured by quantitative muscle testing (≤ 5% lower limit of normal for stratified age)
  • Confirmed diagnosis of LOPD
  • On enzyme replacement therapy for ≥ 26 weeks at pretest
  • Able to follow directions for study participation
  • Able to complete a home-based LMT regimen
  • Access to reliable internet connection
  • Access to use of electronic device that allows for FaceTime, Jabber, or WebEx use

Exclusion criteria

Exclusion Criteria:

  • Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
  • Any current or past history of seizures.
  • Head and neck cancer or radiation treatment to head/neck
  • Inability to tolerate IOPI device tongue bulb
  • Inability to give legally effective consent
  • Inability to read and understand English
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Late Onset Pompe Disease who have tongue weakness

    Other: Lingual Muscle Training

Interventions

  • OtherLingual Muscle Training

    Lingual Muscle Training using the Iowa Oral Performance Instrument (OIPI) device

06

What researchers measure

Primary outcomes

  1. Safety of lingual muscle training

    Safety measured by pain rating scale

    Time frame: 13 weeks

  2. Feasibility of lingual muscle training as measured by questionnaires

    Time frame: 13 weeks

Secondary outcomes

  1. Change in lingual strength

    Change from pre-test to post-test

    Time frame: baseline, 13 weeks

07

Study locations

1 site
  • Duke University Medical Center and affiliated practices
    Durham, North Carolina 27710, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Apr 2020, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2017
First posted
Aug 21, 2017
StartActual
Mar 21, 2018
Primary completionActual
Apr 23, 2020
CompletionActual
Apr 23, 2020
Last update
Jul 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03255213
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Mar 21, 2018
Primary completion
Apr 23, 2020
Completion
Apr 23, 2020
Last update
Jul 28, 2021

Study contacts

Jones Harrison, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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