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

• Sponsor: Assaf-Harofeh Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01329510
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Device: One-night polysomnographic recordings	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: methylphenidate	Device: One-night polysomnographic recordings; One-night polysomnographic recordings before and during methylphenidate treatment.

Outcome Measures

Primary Outcome Measures

1. polysomnographic parameters [one- night (day 1)]

Secondary Outcome Measures

1. sleep questionnaire [one week]

   mini sleep questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ADHD according to DSM-IV Criteria

• Positive ASRS questionnaire

Exclusion Criteria:

• Brain damage

• Brain encephalopathy

• Borderline IQ

• Affective disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assaf Harofeh Medical Center	Zrifin		Israel	70300

Sponsors and Collaborators

• Assaf-Harofeh Medical Center

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01329510
• Other Study ID Numbers: 106/05
• First Posted: Apr 6, 2011
• Last Update Posted: Apr 6, 2011
• Last Verified: Aug 1, 2005

• Keywords provided by , ,: ADHD; Adult
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Apr 6, 2011