Sleep DisordersNCT00945230
Actigraphic Measurement of a Neurosurgical Procedure
A study testing Re-section of a large left anterior cranial fossa meningioma in people with Sleep Disorders and Circadian Rhythm, 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 21 to 75 years, women only
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm, Pain
- What is being tested?
- Re-section of a large left anterior cranial fossa meningioma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of incidental meningioma
- Single subject preparing to receive neurosurgical 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: Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Read the detailed description
Actigraphic measurements, repeated verbal fluency and multi-symptom operationally defined observations will be recorded for an 11 to 12 day baseline period and continued following neurosurgical tumor resection until a repeat MRI is completed three months after the procedure.
- Conditions
- Sleep Disorders, Circadian Rhythm, Pain, Rehabilitation, Mood Lability
- Being tested
- Re-section of a large left anterior cranial fossa meningioma
- Keywords
- Neurosurgical outcome, Actigraphy, Treatment Response Measurement
- Medical subject headings
- Sleep Wake Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-section of a large left anterior cranial fossa meningiomaProcedure or surgery
Also called Actigraphy
Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma
| Study group | Role | What they receive |
|---|---|---|
| Actigraphic Neurosurgical Outcomes | Experimental | Actigraphic measurements that will be obtained by attaching the actigraphic watch device to the individual's non-dominant wrist and operationally defined repeated observational measurements. All measurements will continue through a baseline period and continue through the identified post surgical period. Actigraphic measurements will occur every 30 seconds with brief periods of non-measurement during the actual neurosurgical procedure and periods when the actigraphic device has reached storage capacity (approximately every 22 days) when data is retrieved and the device prepared resume measurements. Receives: Procedure: Re-section of a large left anterior cranial fossa meningioma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and Post Actigraphic and Systematic Observation Scale measurements
Measured: March 15, 2009-June 20, 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies 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
- Collaborators
- Mayo Clinic
- Investigators
- Bill J Duke, M.A., Ph.D., Principal investigator, Child Psychopharmacology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945230
- Sponsor's protocol ID
- Act2NS
- Status last verified
- Jul 2009
- First submitted
- 23 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma
- ClinicalTrials.gov ID
- NCT00945230
- Acronym / sponsor ID
- Act2NS
- Conditions
- Sleep Disorders, Circadian Rhythm, Pain, Rehabilitation, Mood Lability
- Keywords
- Neurosurgical outcome, Actigraphy, Treatment Response Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Child Psychopharmacology InstituteUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
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, repeated verbal fluency and multi-symptom operationally defined observations will be recorded for an 11 to 12 day baseline period and continued following neurosurgical tumor resection until a repeat MRI is completed three months after the procedure.
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 |
|---|---|---|
| Actigraphic Neurosurgical Outcomes | Experimental | Procedure: Re-section of a large left anterior cranial fossa meningiomaActigraphic measurements that will be obtained by attaching the actigraphic watch device to the individual's non-dominant wrist and operationally defined repeated observational measurements. All measurements will continue through a baseline period and continue through the identified post surgical period. Actigraphic measurements will occur every 30 seconds with brief periods of non-measurement during the actual neurosurgical procedure and periods when the actigraphic device has reached storage capacity (approximately every 22 days) when data is retrieved and the device prepared resume measurements. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of incidental meningioma
- Single subject preparing to receive neurosurgical 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 |
|---|---|---|
| Re-section of a large left anterior cranial fossa meningiomaAlso: ActigraphyNeurosurgical re-section of an incidental large left anterior cranial fossa meningioma | Procedure or surgery | Actigraphic Neurosurgical Outcomes |
Primary outcome
Pre and Post Actigraphic and Systematic Observation Scale measurements
Time frame: March 15, 2009-June 20, 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2009.
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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 Re-section of a large left anterior cranial fossa meningioma in people with Sleep Disorders and Circadian Rhythm, 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 2 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 24 Jul 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pre and Post Actigraphic and Systematic Observation Scale measurements (time frame: March 15, 2009-June 20, 2009). 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 24 Jul 2009.