Actigraphic Analysis of Treatment Response

Insomnia Clinical Trial

Official title:

Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723580
• Other study ID #: Act1
• Status: Completed
• Phase: N/A
• First received: July 24, 2008
• Last updated: July 28, 2015
• Start date: May 2008
• Est. completion date: August 2010

Study information

• Verified date: July 2015
• Source: Child Psychopharmacology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 2 Years to 10 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Kabuki Syndrome

• Medication Naive

• Single subject preparing to receive pharmacological intervention

Exclusion Criteria:

• Inability to wear actigraphy device

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Insomnia
• Parasomnias
• Psychomotor Agitation
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

Drug:
• risperidone
Five treatment conditions: 1. Baseline no medication 2. Risperidone .25 mg at bedtime (q.h.s.) x 7 days 3. Risperidone .25 mg twice daily (b.i.d.) 4. Risperidone .25 mg three times a day (t.i.d.) and 5. Risperidone .5 mg three times a day (t.i.d.).

Locations

Country	Name	City	State
United States	Child Psychopharmacology Institute	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Child Psychopharmacology Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraphic Measurement of Treatment Conditions	The child's impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.	May 12- July 14, 2010	No
Secondary	Systematic Observation Scale Item: Percentage of Impulsivity Observed	The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.	May-7-2008 to July -14-2010	No
Secondary	Systematic Observation Scale: Percentage of Irritability Observed		May-7-2008 to July -14-2010	No
Secondary	Systematic Observation Scale: Percentage of Distractibility Observed		May-7-2008 to July -14-2010	No
Secondary	Systematic Observation Scale: Percentage of Hyperactivity Observed		May-7-2008 to July -14-2010	No
Secondary	The Personality Inventory for Children: Adjustment Scale	This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced 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 and developmentally associated change.	May-7-2008 to July -14-2010	No
Secondary	The Personality Inventory for Children: Achievement Scale	The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.	May-7-2008 to July -14-2010	No
Secondary	The Personality Inventory for Children: Somatic-Physiological Scale	The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.	May-7-2008 to July -14-2010	No
Secondary	The Personality Inventory for Children: Delinquency Scale	The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.	May 7, 2008-July 14,2010	No
Secondary	The Personality Inventory for Children: Withdrawal Scale	The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function	May-7-2008 to July -14-2010	No
Secondary	The Personality Inventory for Children: Social Skills Scale	The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.	May-7-2008 to July -14-2010	No
Secondary	The Personality Inventory for Children: Family Relations Scale	The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.	May-7-2008 to July -14-2010	No