NCT01966757|Completed
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Sponsor study identifier
observational
57
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Neuronal Ceroid Lipofuscinosis (NCL) also known at Batten's disease is the most common neurodegenerative disorder in children. Families often report the patient has a sleep disturbance. This is a questionnaire to be completed by the family to better understand the sleep pattern and sleep difficulties experienced by individuals who have been diagnosed with NCL.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 25, 2013
Actual (reported)October 22, 2013
Actual (reported)July 2016
Actual (reported)July 2016
Actual (reported)Sleep disturbance
Identify the presence of sleep disturbance in children with Neuronal Ceroid Lipofuscinosis using the Children's Sleep Habits Questionnaire (CSHQ) and using the 8 subscales further identify specific areas of difficulty
one year
Epilepsy onset
one year
Blindness
one year
Caregiver of patient with NCL to provide information regarding patient's sleep habits
Patient with a known diagnosis of Neuronal Ceroid Lipofuscinosis by biopsy or genetic testing
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
Lehwald LM, Pappa R, Steward S, de Los Reyes E. Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities. Pediatr Neurol. 2016 Jun;59:30-5. doi: 10.1016/j.pediatrneurol.2016.02.009. Epub 2016 Mar 3.
Lenora M Lehwald, MD
Nationwide Children's Hospital
57 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2013
First Posted
October 22, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Gene Therapy Trial for CLN6 Batten Disease
Contact the study team to confirm eligibility.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
July 26, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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