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Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools

Study acronym: SOUTIEN-PC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Feb 2025 to Feb 2027v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary and study completion dates: Feb 2023 to Feb 2025v4
  4. Secondary endpoints: details revised at 1 of 5 entries
    • Eligibility criteria shortened, about 5 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 2021 to Feb 2023
    • Start date changed from estimate of Jun 2019 to Jan 12, 2021
    • Site details revised at 6 of 6 sites
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.
Trial Details
NCT Number NCT03915418
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)		 Sleep Disorders
Related terms Cerebral Palsy, Sleep Wake Disorders
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov