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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
One-night polysomnographic recordings
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Adult

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Brain damage
  • Brain encephalopathy
  • Borderline IQ
  • Affective disorder

Sites / Locations

  • Assaf Harofeh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

methylphenidate

Arm Description

Outcomes

Primary Outcome Measures

polysomnographic parameters

Secondary Outcome Measures

sleep questionnaire
mini sleep questionnaire

Full Information

First Posted
September 1, 2010
Last Updated
April 5, 2011
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01329510
Brief Title
Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Acronym
ADHD
Official Title
The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Adult

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methylphenidate
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
One-night polysomnographic recordings
Intervention Description
One-night polysomnographic recordings before and during methylphenidate treatment.
Primary Outcome Measure Information:
Title
polysomnographic parameters
Time Frame
one- night (day 1)
Secondary Outcome Measure Information:
Title
sleep questionnaire
Description
mini sleep questionnaire
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ADHD according to DSM-IV Criteria Positive ASRS questionnaire Exclusion Criteria: Brain damage Brain encephalopathy Borderline IQ Affective disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Khaigrekht, MD
Organizational Affiliation
Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ran Shorer, M.A.
Organizational Affiliation
Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Rabey, MD
Organizational Affiliation
Neurology Department , Assaf Harofeh Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Itzhak Shpirer, MD
Organizational Affiliation
Sleep And Snoring Clinic, Assaf Harofeh Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shoky Shavit, M.A
Organizational Affiliation
Memory, Attention And Learning Disabilities Clinic, Assaf Harofeh Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zrifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

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

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