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Trial record 1 of 3 for:    valkee
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The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938937
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : February 26, 2014
Sponsor:
Collaborator:
Valkee Oy
Information provided by (Responsible Party):
Heidi Jurvelin, University of Oulu

Tracking Information
First Submitted Date  ICMJE September 5, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date February 26, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Change in total score of STAI-Y1 [ Time Frame: just before exposure, 10 minutes and 110 minutes after the exposure ]
STAI-Y1 (Spielberger State-Trait Anxiety Inventory, form Y1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Official Title  ICMJE The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Brief Summary The purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.
Detailed Description Subjects (n=30) with anxiety symptoms will be recruited into the study. To be included into the study, subjects have to get at least seven points in BAI(Becks Anxiety Inventory). At the beginning of the study subject will be randomly assigned to 12 minutes of acute transcranial bright light or placebo exposure group. Anxiety symptoms will be measured using Spielberger State-Trait Anxiety Inventory (STAI, form Y1)self-rating questionnaire just before and 10 and 110 minutes after the experiment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE
  • Device: Transcranial bright light device
    Other Name: Valkee npt 1100
  • Device: Transcranial sham device
    Other Name: Valkee npt 1100
Study Arms  ICMJE
  • Experimental: Transcranial bright light exposure
    Transcranially administered bright light exposure for 12 minutes
    Intervention: Device: Transcranial bright light device
  • Sham Comparator: Transcranial sham exposure
    Transcranially administered sham exposure for 12 minutes
    Intervention: Device: Transcranial sham device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject can read and understand the study protocol
  • The written informed consent is obtained from subject
  • Subject's BAI total score >= 7

Exclusion Criteria:

  • Subject has a lifetime psychotic disorder
  • Subject abuses substance or has a dependence
  • Subject has had suicidal idealization during the past month
  • Subject use psychotropic medications
  • Subject has unstable somatic disease
  • Subject has used bright-light therapy for the current episode
  • Subject is pregnant
  • Subject is a relative of a member of research team
  • Subject has used transcranial light treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938937
Other Study ID Numbers  ICMJE ANX-a
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heidi Jurvelin, University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Valkee Oy
Investigators  ICMJE Not Provided
PRS Account University of Oulu
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP