Sleep Quality in Adolescents With Idiopathic Scoliosis

Study acronym: AIS-SLEEP
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Recruitment opened
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 7 of 7 entries
  2. Study First Submitted
  • 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.
This controlled cross-sectional observational study aims to compare sleep quality between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls. Participants aged 10-18 years will complete online questionnaires assessing demographic characteristics and sleep quality. Adolescents with idiopathic scoliosis will also be evaluated for scoliosis-specific quality of life, body image, Cobb angle, curve type, pain, brace use, and daily brace-wearing duration. The study will additionally investigate factors associated with sleep quality in the scoliosis group. The planned enrollment is 100 participants, including 50 adolescents with idiopathic scoliosis and 50 healthy controls.
Trial Details
NCT Number NCT07767591
Lead Sponsor Bezmialem Vakif University
Conditions
(from sponsor)		 Adolescent, Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
Related terms Scoliosis, Sleep Initiation and Maintenance Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov