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Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD) (ADHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329510
First Posted: April 6, 2011
Last Update Posted: April 6, 2011
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.
Information provided by:
Assaf-Harofeh Medical Center
September 1, 2010
April 6, 2011
April 6, 2011
August 2005
December 2006   (Final data collection date for primary outcome measure)
polysomnographic parameters [ Time Frame: one- night (day 1) ]
Same as current
No Changes Posted
sleep questionnaire [ Time Frame: one week ]
mini sleep questionnaire
Same as current
Not Provided
Not Provided
 
Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study
This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.

Previous studies in children with Attention Deficit/ Hyperactivity Disorder (ADHD) have described the effect of stimulants on sleep patterns. However the data on adults with ADHD is sparse.

The aim of this study is to investigate the effects of methylphenidate on sleep in adults with ADHD using polysomnographic parameters.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Attention Deficit Hyperactivity Disorder
Device: One-night polysomnographic recordings
One-night polysomnographic recordings before and during methylphenidate treatment.
Experimental: methylphenidate
Intervention: Device: One-night polysomnographic recordings
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
May 2007
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ADHD according to DSM-IV Criteria
  • Positive ASRS questionnaire

Exclusion Criteria:

  • Brain damage
  • Brain encephalopathy
  • Borderline IQ
  • Affective disorder
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01329510
106/05
No
Not Provided
Not Provided
Dr. Shpirer Itzhak, Sleep & Snoring Clinic, Assaf Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Study Director: Michael Khaigrekht, MD Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Study Director: Ran Shorer, M.A. Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Study Director: Martin Rabey, MD Neurology Department , Assaf Harofeh Medical Center
Principal Investigator: Itzhak Shpirer, MD Sleep And Snoring Clinic, Assaf Harofeh Medical Center
Study Director: Shoky Shavit, M.A Memory, Attention And Learning Disabilities Clinic, Assaf Harofeh Medical Center
Assaf-Harofeh Medical Center
August 2005

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