Circadian Phase Assessments at Home

Not Applicable

Completed

• Conditions: Healthy Controls; Delayed Sleep Phase
• Interventions: Behavioral: At home saliva sampling

• Registration Number: NCT01487252
• Lead Sponsor: Rush University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Healthy adult volunteers or people with Delayed Sleep Phase Disorder

Exclusion Criteria

• Color blindness with the Ishihara test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Controls	At home saliva sampling	-
Delayed Sleep Phase Disorder	At home saliva sampling	-

Primary Outcome Measures

Name	Time	Method
Dim Light Melatonin Onset	9 days	The DLMO is assessed twice at home and twice in the laboratory.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States