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

NCT ID: NCT01329510

Last Updated: 2011-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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methylphenidate

Group Type EXPERIMENTAL

One-night polysomnographic recordings

Intervention Type DEVICE

One-night polysomnographic recordings before and during methylphenidate treatment.

Interventions

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One-night polysomnographic recordings

One-night polysomnographic recordings before and during methylphenidate treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Brain damage
* Brain encephalopathy
* Borderline IQ
* Affective disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sleep & Snoring Clinic, Assaf Harofeh Medical Center

Principal Investigators

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Michael Khaigrekht, MD

Role: STUDY_DIRECTOR

Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center

Ran Shorer, M.A.

Role: STUDY_DIRECTOR

Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center

Martin Rabey, MD

Role: STUDY_DIRECTOR

Neurology Department , Assaf Harofeh Medical Center

Itzhak Shpirer, MD

Role: PRINCIPAL_INVESTIGATOR

Sleep And Snoring Clinic, Assaf Harofeh Medical Center

Shoky Shavit, M.A

Role: STUDY_DIRECTOR

Memory, Attention And Learning Disabilities Clinic, Assaf Harofeh Medical Center

Locations

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Assaf Harofeh Medical Center

Zrifin, Zrifin, Israel

Site Status

Countries

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Israel

Other Identifiers

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106/05

Identifier Type: -

Identifier Source: org_study_id

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