We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Synchronization and Desynchronization Between Circadian Rhythms in Patients With Delayed Sleep Phase Syndrome (DSPS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282061
First Posted: January 25, 2006
Last Update Posted: December 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
This study's first aim is to widen the knowledge of the characteristics of delayed sleep phase disorder (DSPS) by focusing on the circadian rhythms of appetite regulation factors and their phase relations to the cycles of sleep-wake, melatonin, cortisol and body temperature. This study's second aim is to assess the influence of forced morning awakening, as a daily struggle faced by DSPS patients, upon the synchronization of these variables in DSPS patients. The investigators hypothesize that the chronic incompatibility between the endogenous sleep-wake rhythm of the DSPS patients and the morning wakefulness, as a social demand, may impair the synchronization between the different rhythms, as findings indicate in normal subjects under jet lag. And finally, the third aim of the study is to assess the influence of successful treatment with melatonin upon the phase locations of circadian rhythms of studied measures and the synchronization between them. These measures will be assessed in a controlled study, for 36 hours (sampled every 2 hours) under three distinct experimental conditions: first, under free sleep-wake conditions (ad-libitum bedtime and arousal); second, under restricted sleep-wake conditions (enforced morning wake-up); and finally, after 12 weeks of melatonin treatment.

Condition Intervention Phase
Delayed Sleep Phase Syndrome Drug: Melatonin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of DSPS

Exclusion Criteria:

  • BMI higher than 28 or lower than 22
  • Shift-work
  • Chronic disease and chronic medication use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282061


Contacts
Contact: Julia Tamir, MA 972-54-811146 julia.tamir@sheba.health.gov.il

Locations
Israel
The Institute for Sleep and Fatigue Medicine, Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Julia Tamir, MA    972-54-4811146    julia.tamir@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Yaron Dagan, MD, PhD Sheba Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00282061     History of Changes
Other Study ID Numbers: SHEBA-04-3497-YD-CTIL
First Submitted: January 24, 2006
First Posted: January 25, 2006
Last Update Posted: December 15, 2006
Last Verified: January 2006

Keywords provided by Sheba Medical Center:
3 conditions in a within-subject design:
1-ad-lib sleep wake
2-forced morning wake-up
3- ad-lib sleep wake after treatment with melatonin

Additional relevant MeSH terms:
Syndrome
Sleep Disorders, Circadian Rhythm
Disease
Pathologic Processes
Chronobiology Disorders
Nervous System Diseases
Dyssomnias
Sleep Wake Disorders
Occupational Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants