Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities Before Handling the Disorder?

November 9, 2016 updated by: Lilach Kemer

Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities (Attention and Concentration, Mood and Fatigue) Before Handling the Disorder? And Whether the Treatment Fixes the Disorder?

The purpose of this study is to determine whether the known treatment for DSPS also improve the cognitive ability and mood of the patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Every participant will take a few test and tasks that are going to test his cognitive ability and mood before treatment in 08:00 and 20:00, and again the same tests at the same hours after the treatment.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with DSPS

Exclusion Criteria:

  • attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Base line
the subject will take the tests in the morning and the evening
EXPERIMENTAL: After treatment
the subject will take the tests in the morning and the evening
Other: Melatonin and light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep patterns
Time Frame: 1 week
Sleep actigraph
1 week
Melatonin secretion
Time Frame: 12 hours
Melatonin -Sulfate Urine
12 hours
Brief Symptom Inventory
Time Frame: 1 day
BSI Questionnaire- assess the subject's emotional state
1 day
Epworth Sleepiness Scale
Time Frame: 1 day
ESS Questionnaire- measure daytime sleepiness
1 day
Karolinska Sleepiness Scale
Time Frame: 1 day
KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness
1 day
Continuous Performance Test 3
Time Frame: 1 day
Task-oriented computerized assessment of attention-related problems
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lilach Kemer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

November 1, 2017

Study Registration Dates

First Submitted

October 30, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (ESTIMATE)

November 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0092-16-ASMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Delayed Sleep Phase Syndrome

Clinical Trials on Melatonin and light therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe