Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Northwestern University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This study investigates the relationship between the noradrenergic (NA) system, sleep quality, and cognitive function in older adults with insomnia - a population at elevated risk for Alzheimer's disease-related dementias (ADRD) - compared to age and sex matched controls with normal sleep. The study characterizes NA function through multiple approaches: measuring 24-hour plasma levels of norepinephrine (NE) and its brain metabolite 3-methoxy-4-hydroxyphenylglycol (MHPG); evaluating central NA system response using the clonidine suppression test (a presynaptic α2 adrenoreceptor agonist that reduces locus coeruleus NA activity; and employing pupillometry as a non-invasive marker of autonomic function. To explore NA function's mechanistic role in insomnia, the study uses an intervention with bright light exposure to enhance daytime NA activity, with the goal of improving both sleep quality and cognitive performance.
Is light exposure a promising treatment for insomnia?Yes, light exposure, specifically bright light therapy, is a promising treatment for insomnia. It can help improve sleep by adjusting the body's internal clock, especially for those who wake up too early. Studies show it can increase total sleep time and improve sleep quality without using drugs.234911
What data supports the idea that Light Exposure for Insomnia is an effective treatment?The available research shows that Light Exposure for Insomnia can significantly improve sleep quality. A systematic review and meta-analysis of 22 studies with 685 participants found that light therapy helped reduce the time people stayed awake after initially falling asleep by about 11 minutes. This suggests that light therapy can be a helpful alternative to sleeping pills for managing insomnia. Additionally, light therapy is already known to be effective for other conditions like mood disorders and seasonal affective disorder, which supports its potential benefits for insomnia as well.4561011
What safety data exists for light therapy in treating insomnia?Light therapy, also known as bright light therapy or phototherapy, has been studied for its safety and side effects. Common side effects reported include headache, eye strain, irritability, and nausea, particularly in psychiatric populations. However, studies in healthy individuals and those with insomnia have shown minimal side effects, with some reporting blurring as a more frequent occurrence. Innovative light setups have been shown to minimize these side effects, enhancing patient adherence. Overall, light therapy is considered to have few and generally mild side effects.1781112
Do I have to stop taking my current medications for the trial?Yes, you must stop taking certain medications. The trial excludes participants who are currently using or have used in the past month psychoactive, hypnotic, stimulant, or analgesic medications (except occasionally). It also excludes those using medications that interfere with the NA system, such as B-blockers, SNRIs, and NDRIs, as well as medications affecting pupil diameter and responses to light, like antihistamines, anticholinergics, benzodiazepines, and narcotics for pain.
Eligibility Criteria
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.Inclusion Criteria
I have been diagnosed with chronic insomnia.
I've been awake for 60+ minutes in the middle of the night, at least 3 nights a week for the last month.
I am a woman who has gone through menopause.
I have never been diagnosed with insomnia.
I am 55 years old or older.
Exclusion Criteria
I am not taking medications like B-blockers or SNRIs that affect the nervous system.
I have a history of heart conditions.
I have a history of mental health issues.
I have eye conditions like severe cataracts, glaucoma, or blindness that affect my vision.
I do not have any serious or unstable health conditions.
I have a history of neurological disorders.
I am on hormone replacement therapy.
I have a sleep disorder other than insomnia.
I am not taking medications that affect my pupils.
Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Northwestern University Feinberg School of Medicine, Center for Circadian and Sleep MedicineChicago, IL
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Side-effects of phototherapy in nonseasonal depressive disorder. [2004]The data of the Berlin light therapy study were systematically reinvestigated for side-effects of light therapy as described in the literature. Forty-two patients with major depressive disorder (RDC), who also met the criteria of ICD-9 (296.1 and 296.3), were included. Patients were either given bright white-light treatment (2,500 lux) or dim red-light treatment (50 lux) from 7.20 a.m. to 9.20 a.m. every morning for a period of seven days. The study did not reveal any differences in side-effects between the two treatments. The results are discussed in relation to the two different treatment conditions.
The effect of evening bright light in delaying the circadian rhythms and lengthening the sleep of early morning awakening insomniacs. [2019]Past studies have predicted that early morning awakening insomnia is associated with advanced or early circadian rhythms. Because bright light stimulation in the evening can delay the phase of circadian rhythms, we tested its effects on nine (4 females, 5 males) early morning awakening insomniacs. Their sleep was evaluated with wrist actigraphy and their temperature and melatonin circadian rhythms were measured in constant routine procedures. In the initial evaluation, the temperature rhythm phase positions of these insomniacs did appear to be earlier than normal. The subjects were then exposed to bright light stimulation (2,500 lux) from 2000 to 2400 hours on two consecutive evenings. Following the evening bright light treatment, temperature rhythm phase markers were delayed 2-4 hours and melatonin phase markers were delayed 1-2 hours. Sleep onset times were not changed but the mean final wake-up time was delayed from 0459 hours to 0611 hours, resulting in a mean increase of total sleep time of > 1 hour. This pilot study suggests that evening bright light stimulation may be an effective nondrug treatment for early morning awakening insomnia.
[Photoperiod phototherapy and wakefulness-sleep rhythm disorders]. [2006]Bright light therapy is a recent physical treatment in chronodisabled situations. The most recognized indication is the seasonal affective disorder. However, any disease or dysfunction where a misalignment of sleep-wake and circadian rhythms may be suspected is a potential tool for this treatment. Analyses of the literature throughout the interpretation methods of the evidence based medicine indicate that bright light therapy, if not a standard, could be recommended in a number of circadian rhythm sleep disorders, mainly the delayed and advanced sleep phase syndromes. Time aspects are essential for the success of phototherapy. From this point of view, easy and practical technological means or methods, allowing to shape a Phase Response Curve in each individual to be treated, should be clear progress. A future extension of indications will also depend on the checking of essential hypotheses linking circadian and sleep-wake rhythms in diseases such as psychophysiological insomnia, multiple sclerosis, brain dysgeneses or dementias. At last, a non negligible advantage of bright light therapy appears to be its relative safety.
The treatment of early-morning awakening insomnia with 2 evenings of bright light. [2019]To assess the effectiveness of brief bright-light therapy for the treatment of early-morning awakening insomnia.
Scheduled bright light for treatment of insomnia in older adults. [2021]To determine whether bright light can improve sleep in older individuals with insomnia.
Illuminating rationale and uses for light therapy. [2021]Light therapy is increasingly applied in a variety of sleep medicine and psychiatric conditions including circadian rhythm sleep disorders, seasonal affective disorder, and dementia. This article reviews the neural underpinnings of circadian neurobiology crucial for understanding the influence of light therapy on brain function, common mood and sleep disorders in which light therapy may be effectively used, and applications of light therapy in clinical practice.
The acute side effects of bright light therapy: a placebo-controlled investigation. [2023]Despite the emergence of numerous clinical and non-clinical applications of bright light therapy (LT) in recent decades, the prevalence and severity of LT side effects have not yet been fully explicated. A few adverse LT effects-headache, eye strain, irritability, and nausea-have been consistently reported among depressed individuals and other psychiatric cohorts, but there exists little published evidence regarding LT side effects in non-clinical populations, who often undergo LT treatment of considerably briefer duration. Accordingly, in the present study we examined, in a randomized sample of healthy young adults, the acute side effects of exposure to a single 30-minute session of bright white light (10,000 lux) versus dim red light (
Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]Abstract Objective. Bright light therapy (BLT) is regarded to be an effective treatment against seasonal depression (SAD). Conventional BLT devices are reported to evoke few, but inconvenient symptoms. This study evaluated side effects associated with a new technology for BLT in a healthy population. Methods. In an uncontrolled study design 20 healthy Caucasians received 30 min light exposures on three consecutive mornings. Immediate side effects were evaluated using questionnaires. The new light cabin was equipped with fluorescent lamps (light colour 965 = 6,500 K, CRI >90) with a maximum illumination of 5,000 lux and a maximum luminance of 1,500 cd/m(2). Occurrence of headache was determined to be the main objective. Results. Nineteen volunteers completed the study. No headache was reported at any time. With a prevalence of 21.1% blurring was observed to occur more often after light exposure. Conclusion. With the evaluated light cabin the most prominent short-term side effects of BLT can be minimized, enhancing patients' adherence.
[Treating circadian sleep-wake disorders by light]. [2019]Phototherapy is one treatment of circadian sleep-wake disorders, which is based on consensual and numerous scientific and clinical evidences. Phototherapy efficiency depends on several light characteristics based on intensity, length of exposure, time of exposure and wavelength. Phototherapy is potentially indicated in the following circadian disorders: advanced sleep-wake phase disorder (ASWPD), delayed sleep-wake phase disorder (DSWPD), non-24-hour sleep-wake rhythm disorder (N24SWD), jet-lag and night-shift work sleep-wake disorders (NSSWD). Phototherapy, acting via the retina, may be avoided in patients with retina disorders, an ophthalmologist should be consulted.
CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]Light therapy has become established as an evidence-based treatment for Seasonal Affective Disorder. Light impacts the timing and stability of circadian rhythms as expressed in sleep, mood, alertness, and cognition. Forty years of clinical trials and open treatment have led to guidelines for patient selection, using light alone or in combination with antidepressants (or lithium for bipolar depression). Mood and sleep disturbances can also respond to adjunct light therapy in a broader set of psychiatric, neurologic and medical illnesses. We specify criteria for choice of treatment devices: optimum dose (10,000 lux), spectrum (white light), exposure duration (30-60 minutes) and timing (early morning). Protocol adjustment requires continual monitoring with attention to rate of improvement and management of potential side effects.
Light therapy in insomnia disorder: A systematic review and meta-analysis. [2023]In the management of insomnia, physicians and patients are seeking alternative therapeutics to sleeping pills, in addition to sleep hygiene and cognitive behavioural therapy. Bright light therapy (LT) has proven its efficacy in circadian and mood disorders. We conducted a systematic literature review and meta-analysis according to Cochrane and PRISMA guidelines and using the databases Medline, Cochrane, and Web of Science, with a special focus on light therapy and insomnia. Twenty-two studies with a total of 685 participants were included, five of which with a high level of proof. Meta-analysis was performed with 13 of them: light therapy for insomnia compared with control conditions significantly improved wake after sleep onset (WASO: SMD = -0.61 [-1.11, -0.11]; p = 0.017; weighted difference of 11.2 min ±11.5 based on actigraphy, and SMD = -1.09 [-1.43, -0.74] (p
Feasibility and Efficacy of Morning Light Therapy for Adults with Insomnia: A Pilot, Randomized, Open-Label, Two-Arm Study. [2023]Background and Objectives: Light therapy (LT) is used as an adjunctive treatment for sleep problems. This study evaluates the impact of LT on sleep quality and sleep-related parameters in patients with sleep disorders. Materials and Methods: We performed a pilot, randomized, open-label clinical trial. Fourteen patients aged 20-60 years with insomnia were randomized into the control and LT groups (1:1 ratio). The LT group was instructed to use a device that provides bright LT (6000 K, 380 lux, wavelength 480 nm) for at least 25 min before 09:00 a.m. for two weeks. A self-reported questionnaire was used to evaluate circadian preference, mood, and sleep-related parameters. We analyzed serum cortisol levels and clock genes' expression. Results: The Epworth Sleepiness Scale (ESS), insomnia severity index(ISI), and Pittsburgh Sleep Quality index(PSQI) were significantly improved within the LT group only after the two-week period. When comparing the two groups, only the change in ESS was significant (mean difference, control: -0.14 vs. LT: -1.43, p = 0.021) after adjusting for the baseline characteristics. There were no significant differences in serum cortisol or clock genes' expression. Conclusions: LT can improve daytime sleepiness in patients with sleep disorders; however, further well-designed studies are warranted to confirm its efficacy.