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Expiratory Muscle Strength Training for Hypernasal Speech in Children

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 9 words
    • Study description shortened, about 18 words
    • Study arms: 4 to 3
    v11
  2. Notable Primary completion date: May 2026 to May 2027
    • Study completion date: Nov 2026 to Nov 2027
    • Start date changed from estimate of Mar 2025 to Mar 3, 2025
    • Site contact updated
    v10
  3. Notable Trial status: Not Yet Recruiting to Recruitingv9 Show 6 more changesShow less
    • Primary completion date: Mar 2026 to May 2026
    • Study completion date: Sep 2026 to Nov 2026
    • Start date: Jan 2025 to Mar 2025
    • Site details revised
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 1 word
  4. Notable Start date: Sep 2024 to Jan 2025
    • Primary completion date: Nov 2025 to Mar 2026
    • Study completion date: May 2026 to Sep 2026
    • Site contact updated
    v8
  5. Notable Primary completion date: Feb 2025 to Nov 2025
    • Start date: Feb 2024 to Sep 2024
    • Study completion date: Sep 2025 to May 2026
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Start date: Oct 2023 to Feb 2024
    • Primary completion date: Oct 2024 to Feb 2025
    • Study completion date: May 2025 to Sep 2025
    v6
  2. Notable Start date: Jul 2023 to Oct 2023
    • Primary completion date: Jul 2024 to Oct 2024
    • Study completion date: Feb 2025 to May 2025
    v5
  3. Notable Start date: Jan 2023 to Jul 2023
    • Primary completion date: Jan 2024 to Jul 2024
    • Study completion date: Aug 2024 to Feb 2025
    v4
  4. Notable Start date: Nov 2022 to Jan 2023
    • Primary completion date: Nov 2023 to Jan 2024
    • Study completion date: Jul 2024 to Aug 2024
    v3
  5. Notable Start date: Aug 2022 to Nov 2022
    • Primary completion date: Aug 2023 to Nov 2023
    • Study completion date: Apr 2024 to Jul 2024
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.
Trial Details
NCT Number NCT05492266
Lead Sponsor Noel Jabbour
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)
Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence, Hypernasality
Related terms Cleft Palate, Speech Intelligibility, Velopharyngeal Insufficiency
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov