Actigraphic Analysis of Treatment Response
Condition: Sleep Disorders, Circadian Rhythm; Insomnia; Psychomotor Agitation
MeSH terms: Sleep Wake Disorders; Psychomotor Agitation; Sleep Disorders, Circadian Rhythm
Study type: Interventional

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

Detailed 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.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention description(s): 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.).
Other intervention name(s): Actigraphic measurements
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Kabuki Syndrome; Actigraphy; Treatment Response Measurement