Insomnia Clinical Trial
Official title:
Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11
day baseline period, followed by a 10 day period of the initial pharmacological
interventions. The non-invasive nature of watch-like actigraphy devices is particularly
attractive for use in pediatric populations. Meaningful treatment response measurements are
obtained when actigraphic data is combined with psychometric and observational repeated
measurements. Subsequent to the initial data collection the parent consented and the child
assented to extend the study and continue measurements.
The case study included baseline and repeated psychological, observational and actigraphic
measurements that were initiated prior to treatment with risperidone and repeated throughout
the treatment process with the final data collected in July 2010.
The Personality Inventory for Children (PIC) is an objective multidimensional measurement of
affect, behavior, ability and family function. The PIC was administered prior to treatment
with risperidone and repeated after 22 months of treatment. The PIC serves as both an
actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement
indicating treatment associated change.
A primary observer (mother) was trained to report symptom percentages present since previous
observations utilizing the operationally defined and observer defined items of the
systematic observation scale throughout the treatment process.
Actigraphic measurements provide a basis by which to measure sleep and sleep onset latency
as well as periods of mobility and immobility. When programmed to record activity every
thirty seconds, thousands of measurements are quickly captured.
Actigraphic measurements were made utilizing a watch-like actigraphic device with an 11 day
baseline actigraphic measurement period and continued measurements that included the
initiation of a Once-Daily, Bedtime (q.h.s.) pharmacological intervention for 6 days,
followed by a planned adjustment to Twice a Day (b.i.d.) dosing that was measured for an
additional 4 days. Repeated actigraphic studies were subsequently conducted after 22 months
of risperidone treatment and were collected along with the repeated observational and
psychometric data.
This case study explores activity and sleep characteristics related to behavioral
characteristics and treatment response and the utility of single subject repeated
actigraphic, psychometric and observational measurements and monitoring of treatment
response.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
Completed |
NCT06339853 -
Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
|
N/A | |
Recruiting |
NCT04069247 -
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
|
N/A | |
Completed |
NCT04493593 -
Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility
|
N/A | |
Recruiting |
NCT06278077 -
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
|
Phase 2 | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
Recruiting |
NCT06207279 -
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
|
||
Recruiting |
NCT06006299 -
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Completed |
NCT04035200 -
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
|
Phase 2 | |
Active, not recruiting |
NCT05027438 -
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
|
N/A | |
Recruiting |
NCT06053840 -
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
|
Phase 4 | |
Not yet recruiting |
NCT06348082 -
Project Women's Insomnia Sleep Health Equity Study (WISHES)
|
N/A | |
Not yet recruiting |
NCT06363799 -
Osteopathic Protocol for Insomnia in College Students
|
N/A | |
Not yet recruiting |
NCT06025968 -
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
|
N/A | |
Not yet recruiting |
NCT05991492 -
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
|
N/A |