Attention Deficit Hyperactivity DisorderADHDNCT01329510
Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing One-night polysomnographic recordings in people with Attention Deficit Hyperactivity Disorder, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- One-night polysomnographic recordings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ADHD according to DSM-IV Criteria
- Positive ASRS questionnaire
Who cannot join
- Brain damage
- Brain encephalopathy
- Borderline IQ
- Affective disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- One-night polysomnographic recordings
- Keywords
- ADHD, Adult
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-night polysomnographic recordingsDevice
One-night polysomnographic recordings before and during methylphenidate treatment.
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate | Experimental | Not described Receives: Device: One-night polysomnographic recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
polysomnographic parameters
Measured: one- night (day 1)
Secondary outcomes (1)
sleep questionnaire
mini sleep questionnaire
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startAug 2005
- Primary completionDec 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Michael Khaigrekht, MD, Study director, Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical CenterRan Shorer, M.A., Study director, Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical CenterMartin Rabey, MD, Study director, Neurology Department , Assaf Harofeh Medical CenterItzhak Shpirer, MD, Principal investigator, Sleep And Snoring Clinic, Assaf Harofeh Medical CenterShoky Shavit, M.A, Study director, Memory, Attention And Learning Disabilities Clinic, Assaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329510
- Sponsor's protocol ID
- 106/05
- Acronym
- ADHD
- Status last verified
- Aug 2005
- First submitted
- 1 Sep 2010
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study
- ClinicalTrials.gov ID
- NCT01329510
- Acronym / sponsor ID
- ADHD / 106/05
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Aug 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methylphenidate | Experimental | Device: One-night polysomnographic recordings |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ADHD according to DSM-IV Criteria
- Positive ASRS questionnaire
Key exclusion criteria (4 listed)
- Brain damage
- Brain encephalopathy
- Borderline IQ
- Affective disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-night polysomnographic recordingsOne-night polysomnographic recordings before and during methylphenidate treatment. | Device | methylphenidate |
Primary outcome
polysomnographic parameters
Time frame: one- night (day 1)
1 secondary outcome
sleep questionnaire
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Khaigrekht, MD study director
Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Ran Shorer, M.A. study director
Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Martin Rabey, MD study director
Neurology Department , Assaf Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-night polysomnographic recordings in people with Attention Deficit Hyperactivity Disorder, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polysomnographic parameters (time frame: one- night (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.