Circadian Phase Assessments at Home

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen Burgess, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01487252
First received: December 2, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

An estimated 23 million Americans, including adolescents and the elderly, suffer from circadian rhythm sleep disorders, such as delayed sleep phase disorder, advanced sleep phase disorder and winter depression. These conditions are characterized by persistent insomnia and/or excessive daytime sleepiness, impaired performance, reduced well being and lower quality of life. The negative symptoms result from a misalignment between the timing of sleep and the internal circadian clock. Clinical research has demonstrated that circadian rhythm sleep disorders are most effectively diagnosed (differentiated from other causes of insomnia) and treated if each individual patient's circadian phase is known. The timing of the master internal circadian clock is most reliably measured from the onset of the endogenous circadian rhythm of melatonin, a neuroendocrine hormone, as measured in dim light (dim light melatonin onset, or "DLMO"). However to date the reliable and valid assessment of the DLMO is limited to the research laboratory setting.

This study is to test a streamlined procedure for the accurate assessment of circadian phase (DLMO) outside of the laboratory that will provide clinicians and researchers with a novel diagnostic and research tool. In this way the underlying neurobiological cause of a patient's insomnia and/or circadian rhythm disorder can more readily be diagnosed and treated.

Specific Aim 1 is to validate procedures for at-home circadian phase assessment in a sample of healthy people. Validation will occur by (1) objectively measuring compliance to the at-home procedures and (2) comparing DLMOs collected at home to DLMOs collected in the laboratory, in a within-subjects counterbalanced design. Specific Aim 2 is to validate the same at home procedures in patients with delayed sleep phase disorder. Specific Aim 3 is to conduct rigorous analyses to inform future users which subject characteristics and light levels predict (1) compliance to the at home procedures and (2) valid at-home DLMOs.

The results of this 3 year study will have substantial implications for the translation of basic and clinical research to the community: (1) the diagnosis and treatment of insomnia and circadian rhythm sleep disorders will be significantly enhanced, thus improving public health and safety, mood and quality of life, (2) community participation in research will be improved, particularly in vulnerable and under represented populations, thus increasing scientific knowledge and (3) research and clinical costs will be substantially reduced.


Condition Intervention Phase
Healthy Controls
Delayed Sleep Phase Disorder.
Behavioral: At home saliva sampling
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Dim Light Melatonin Onset [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    The DLMO is assessed twice at home and twice in the laboratory.


Estimated Enrollment: 68
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Controls Behavioral: At home saliva sampling
Saliva samples taken every half an hour in evening before bedtime.
Active Comparator: Delayed Sleep Phase Disorder Behavioral: At home saliva sampling
Saliva samples taken every half an hour in evening before bedtime.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult volunteers or people with Delayed Sleep Phase Disorder

Exclusion Criteria:

  • Color blindness with the Ishihara test
  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: NCT01487252

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
  More Information

No publications provided

Responsible Party: Helen Burgess, Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01487252     History of Changes
Other Study ID Numbers: AT007104
Study First Received: December 2, 2011
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014