Sleep Disorders, Circadian RhythmNCT00723580
Actigraphic Analysis of Treatment Response
A study testing risperidone in people with Sleep Disorders, Circadian Rhythm and Insomnia, run by Child Psychopharmacology Institute at 1 site in United States.
Trial summary
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response. Read more about this study
- Who is it for?
- Ages 2 to 10 years, women only
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm, Insomnia, Psychomotor Agitation
- What is being tested?
- risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Kabuki Syndrome
- Medication Naive
- Single subject preparing to receive pharmacological intervention
Who cannot join
- Inability to wear actigraphy device
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Psychopharmacology Institute
Fargo, North Dakota, 58103
About this study
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.
Read the 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.
- Being tested
- risperidone
- Keywords
- Kabuki Syndrome, Actigraphy, Treatment Response Measurement
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders, Psychomotor Agitation, Kabuki syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
Also called Actigraphic measurements
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.).
| Study group | Role | What they receive |
|---|---|---|
| Sleep and Activity by Treatment Condition | Experimental | Actigraphic measurements were obtained by attaching an actigraphic watch device to the child's non-dominant wrist. The measurements will include three separate three week periods beginning with a baseline period and the period in which the child's pharmacological treatment was initiated. Two additional three week actigraphic measurement periods will occur at 22 months post-baseline period and at 23 months post-baseline period. The resulting five treatment conditions were: 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.). Sleep and activity will be evaluated by treatment conditions. Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: May 12- July 14, 2010
Secondary outcomes (11)
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.
Measured: May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Irritability Observed
Measured: May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Distractibility Observed
Measured: May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Hyperactivity Observed
Measured: May-7-2008 to July -14-2010
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.
Measured: May-7-2008 to July -14-2010
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.
Measured: May-7-2008 to July -14-2010
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.
Measured: May-7-2008 to July -14-2010
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.
Measured: May 7, 2008-July 14,2010
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
Measured: May-7-2008 to July -14-2010
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.
Measured: May-7-2008 to July -14-2010
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.
Measured: May-7-2008 to July -14-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Child Psychopharmacology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bill J. Duke, M.A., Ph.D., ABMPP, Child Psychopharmacology Institute
- Investigators
- Bill J Duke, M.A., Ph.D., Principal investigator, Child Psychopharmacology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723580
- Sponsor's protocol ID
- Act1
- Status last verified
- Jul 2015
- First submitted
- 24 Jul 2008
- Last updated
- 18 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
- ClinicalTrials.gov ID
- NCT00723580
- Acronym / sponsor ID
- Act1
- Keywords
- Kabuki Syndrome, Actigraphy, Treatment Response Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Child Psychopharmacology InstituteUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Posted 14 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep and Activity by Treatment Condition | Experimental | Drug: risperidoneActigraphic measurements were obtained by attaching an actigraphic watch device to the child's non-dominant wrist. The measurements will include three separate three week periods beginning with a baseline period and the period in which the child's pharmacological treatment was initiated. Two additional three week actigraphic measurement periods will occur at 22 months post-baseline period and at 23 months post-baseline period. The resulting five treatment conditions were: 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.). Sleep and activity will be evaluated by treatment conditions. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of Kabuki Syndrome
- Medication Naive
- Single subject preparing to receive pharmacological intervention
Key exclusion criteria (1 listed)
- Inability to wear actigraphy device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risperidoneAlso: Actigraphic measurementsFive 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.). | Drug | Sleep and Activity by Treatment Condition |
Primary outcome
Actigraphic Measurement of Treatment Conditions
Time frame: May 12- July 14, 2010
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.
11 secondary outcomes
Systematic Observation Scale Item: Percentage of Impulsivity Observed
Time frame: May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Irritability Observed
Time frame: May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Distractibility Observed
Time frame: May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Hyperactivity Observed
Time frame: May-7-2008 to July -14-2010
The Personality Inventory for Children: Adjustment Scale
Time frame: May-7-2008 to July -14-2010
The Personality Inventory for Children: Achievement Scale
Time frame: May-7-2008 to July -14-2010
The Personality Inventory for Children: Somatic-Physiological Scale
Time frame: May-7-2008 to July -14-2010
The Personality Inventory for Children: Delinquency Scale
Time frame: May 7, 2008-July 14,2010
The Personality Inventory for Children: Withdrawal Scale
Time frame: May-7-2008 to July -14-2010
The Personality Inventory for Children: Social Skills Scale
Time frame: May-7-2008 to July -14-2010
The Personality Inventory for Children: Family Relations Scale
Time frame: May-7-2008 to July -14-2010
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill J Duke, M.A., Ph.D. principal investigator
Child Psychopharmacology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risperidone in people with Sleep Disorders, Circadian Rhythm and Insomnia, run by Child Psychopharmacology Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphic Measurement of Treatment Conditions (time frame: May 12- July 14, 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.