Synchronization and Desynchronization Between Circadian Rhythms in Patients With Delayed Sleep Phase Syndrome (DSPS)
Recruitment status was Recruiting
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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 |
Eligibility| Ages Eligible for Study: | 22 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Julia Tamir, MA | 972-54-811146 | julia.tamir@sheba.health.gov.il |
| 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 | |
| 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 Chronobiology Disorders Nervous System Diseases Dyssomnias Sleep Disorders Occupational Diseases Mental Disorders Melatonin |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013