Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01966757
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
2013-09-25
Brief Title:
Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neuronal Ceroid Lipofuscinosis NCL also known at Battens 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
Detailed Description:
Neuronal Ceroid Lipofuscinosis NCL is the most common neurodegenerative disorder in children characterized by seizures blindness ataxia myoclonia and loss of cognition There are 12 clinical types identified with a concurrent genetic abnormality The diagnosis is determined by gene testing and skin biopsy findings although genetic testing has supplanted skin biopsy in most cases Numberous studies have confirmed the presence of sleep disorder in patients with NCL but these cases were documented over a decade ago The investigators would like to study the prevalence of sleep disorders in this group of patients The investigators will distribute a Childrens Sleep Habits Questionnaire CSHQ to the family of the patient to complete and provide a information regarding the patients sleep In addition to the validated sleep questionnaire a separate demographic questionnaire will be given to the family to identify the type of NCL presence or absence of blindness presence or absence of seizures interventions tried to treat sleep disturbance The last questions of the study are asking for the presence or absence of Restless Leg Syndrome symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None