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Light Exposure for Insomnia (NASC Trial)

N/A

Recruiting

Led By Phyllis C Zee, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.) (for insomnia group)

Subjective WASO (sWASO) ≥ 60 minutes for ≥3 nights/week in previous 4 weeks. sWASO will include time spent awake after sleep onset before final awakening + time spent awake in bed attempting to sleep after the final awakening (for insomnia group)

Must not have

Use of medications that interfere with NA system activity including B-blockers, selective serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective norepinephrine-dopamine reuptake inhibitors (NDRIs)

History of heart conditions (i.e. arrhythmia, coronary artery disease, angina, heart failure)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to the end of treatment at 10 weeks.

Summary

This trial is looking at how the noradrenergic system, which is involved in regulating stress responses, affects the sleep quality and cognitive function of older adults with insomnia, who are at higher risk

Who is the study for?

This trial is for older adults who have trouble sleeping, known as insomnia. Participants should be at risk for memory-related diseases but can't join if they don't match the age and sex criteria or have other factors that could affect the study results.

What is being tested?

The study looks at how a part of the nervous system involved in alertness affects sleep and thinking in those with insomnia. It tests whether bright light exposure during the day can improve sleep quality and mental function by changing this system's activity.

What are the potential side effects?

Since this trial involves light exposure therapy, potential side effects are minimal but may include eye strain or headache. The placebo has no active ingredients, so any side effects would likely be psychological.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic insomnia.

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I've been awake for 60+ minutes in the middle of the night, at least 3 nights a week for the last month.

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I am a woman who has gone through menopause.

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I have never been diagnosed with insomnia.

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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications like B-blockers or SNRIs that affect the nervous system.

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I have a history of heart conditions.

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I have a history of mental health issues.

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I have eye conditions like severe cataracts, glaucoma, or blindness that affect my vision.

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I do not have any serious or unstable health conditions.

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I have a history of neurological disorders.

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I am on hormone replacement therapy.

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I have a sleep disorder other than insomnia.

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I am not taking medications that affect my pupils.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24h plasma norepinephrine

Clonidine suppression test

NIH tool box

+3 more

Secondary study objectives

24-h plasma 3-methoxy-4-hydroxyphenylglycol (MHPG)

24-h plasma cortisol levels

24h plasma melatonin

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention on Subjects with InsomniaExperimental Treatment1 Intervention

The intervention in this study will involve 28 (+4) days of daily exposure to bright light (BL) for two 60-minute sessions (morning and afternoon). For the intervention, we will use Re-Timer® light glasses emitting light with an intensity of 230μW/cm2 (\~500lux) with a green blue 500nm dominant wavelength (between 480-520nm). Light with these characteristics has been shown effective in suppressing melatonin levels supporting their potential to exert effects on other biological non-visual functions associated with exposure to light relevant for this study. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects.

Group II: Dim Red LightActive Control1 Intervention

Participants randomized to the control group will wear for two 60-minute sessions (morning and afternoon) customized dim-red light (RL) control Re-Timer® light glasses (wavelength peak at 632nm, light intensity \< 3 lux). Participants will be instructed to wear the light glasses in habitual indoor environments, without engaging in strenuous activities. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects.

0 / 14Eligibility criteria met