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NCT04761380
Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects
trial testing balloon-based tongue pressure measurement device in Chronic Obstructive Pulmonary Disease in 51 participants. Completed in 10 May 2020.
10 May 2020
Quick facts
| Lead sponsor | Kindai University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 51 |
| Start date | 1 December 2019 |
| Primary completion | 10 May 2020 |
| Estimated completion | 10 May 2020 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- balloon-based tongue pressure measurement device
Conditions studied
- Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
Sponsor
Kindai University
Who can join
65 and older, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (COPD). But tongue strength has not been investigated yet in COPD subjects. The investigators hypothesized that tongue strength is weaker in COPD subjects compared to normal subjects. Methods: This was a single-centre, observational, and cross-sectional study. Twenty-seven subjects with COPD and twenty-four age-matched control subjects were enrolled in this study. Isometric tongue strength was measured using a device fitted with a disposable oral balloon probe. The investigators also evaluated handgrip strength, gait speed, and appendicular skeletal muscle mass (ASM) to define participants as having sarcopenia. ASM, fat free mass index (FFMI), and skeletal muscle mass index (SMI) were measured by bioelectrical impedance analysis. Gait speed was measured using the 6-meter walking test. The eating assessment test-10 (EAT-10) was used to diagnose dysphagia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04761380 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kindai University
- Last refreshed: 18 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04761380.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing