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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00282061
First received: January 24, 2006
Last updated: December 14, 2006
Last verified: January 2006
  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: Open Label
Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

  Eligibility

Ages Eligible for Study:   22 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00282061     History of Changes
Other Study ID Numbers: SHEBA-04-3497-YD-CTIL
Study First Received: January 24, 2006
Last Updated: December 14, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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:
Sleep Disorders, Circadian Rhythm
Syndrome
Chronobiology Disorders
Disease
Dyssomnias
Mental Disorders
Nervous System Diseases
Occupational Diseases
Pathologic Processes
Sleep Disorders
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014