---
title: Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
nct_id: NCT01329510
overall_status: COMPLETED
phase: NA
sponsor: Assaf-Harofeh Medical Center
study_type: INTERVENTIONAL
primary_condition: Attention Deficit Hyperactivity Disorder
countries: Israel
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01329510.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01329510"
ct_last_update_post_date: 2011-04-06
last_seen_at: "2026-05-12T06:07:55.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

**Official Title:** The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study

**NCT ID:** [NCT01329510](https://clinicaltrials.gov/study/NCT01329510)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 19
- **Lead Sponsor:** Assaf-Harofeh Medical Center
- **Conditions:** Attention Deficit Hyperactivity Disorder
- **Start Date:** 2005-08
- **Completion Date:** 2007-05
- **CT.gov Last Update:** 2011-04-06

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

* Brain damage
* Brain encephalopathy
* Borderline IQ
* Affective disorder
```

## Arms

- **methylphenidate** (EXPERIMENTAL)

## Interventions

- **One-night polysomnographic recordings** (DEVICE) — One-night polysomnographic recordings before and during methylphenidate treatment.

## Primary Outcomes

- **polysomnographic parameters** _(time frame: one- night (day 1))_

## Secondary Outcomes

- **sleep questionnaire** _(time frame: one week)_

## Locations (1)

- Assaf Harofeh Medical Center, Zrifin, Zrifin, Israel

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.assaf harofeh medical center|zrifin|zrifin|israel` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01329510*  
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