Sleep and Light Therapy for Circadian Rhythm Disorder
(CARRS-P2 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byBrant Hasler, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Must not be taking: Neuroleptics, Psoralen, Antiarrhythmics
Disqualifiers: Substance use, Psychiatric disorders, Seizures, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times. Many studies find that this increases the risk for substance use (SU). However, what impact circadian rhythm and sleep disruption either together or independently have on the neuronal circuitry that controls reward and cognition, or if there are interventions that might help to modify these disruptions is unknown. Project 2 (P2) of the CARRS center will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it excludes those who have changed their psychotropic medications in the 2 weeks before joining or plan major changes during the study. It also excludes those on medications that increase sensitivity to blue light.
What data supports the effectiveness of the treatment 'Sleep and Light Therapy for Circadian Rhythm Disorder'?
Research shows that light therapy, which is part of this treatment, can improve sleep quality and timing in people with circadian rhythm disorders and certain psychiatric conditions. Additionally, studies on similar therapies, like triple chronotherapy, have shown rapid improvements in mood and sleep patterns, suggesting potential benefits for managing circadian rhythm disorders.
12345Is light therapy safe for treating circadian rhythm disorders?
Research indicates that light therapy, including morning bright light and blue light-blocking glasses, is generally well tolerated and safe for improving sleep and mood in various conditions, such as sleep deprivation and mood disorders.
678910How does sleep and light therapy differ from other treatments for circadian rhythm disorder?
Sleep and light therapy is unique because it uses controlled exposure to light and darkness to adjust the body's internal clock, which can improve sleep patterns and mood. Unlike medications, this treatment focuses on natural environmental cues to regulate circadian rhythms, making it a non-invasive option for managing sleep disorders.
134711Eligibility Criteria
This trial is for healthy teens typically enrolled in high school, who go to bed later than 11:15 PM and are not homeschooled. They can't have metal in their body, be pregnant, have unstable medical conditions, recent changes to psychotropic meds, extreme late sleep patterns, frequent headaches or migraines, a history of substance use or serious psychiatric disorders.Inclusion Criteria
I am enrolled in a traditional high school with live classes.
I am in good physical and mental health.
Provision of written informed consent and assent
+1 more
Exclusion Criteria
I do not have any severe or unstable health conditions.
You have a serious mental health condition, like depression or bipolar disorder, that could make it hard for you to finish the study.
You have used alcohol, cannabis, or illegal drugs in the past month, or more than once a month in the past year.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Observational Study
Participants undergo 2 weeks of home sleep monitoring followed by an overnight laboratory visit for assessments
2 weeks
1 overnight laboratory visit
Experimental Manipulation
Participants in the Late group undergo sleep and circadian rhythm manipulation for approximately 2 weeks
2 weeks
1 initial laboratory visit, followed by home-based intervention
Follow-up
Participants are monitored for changes in sleep and substance use every 6 months
6 months
Participant Groups
The study explores how manipulating sleep and circadian rhythms affects reward function in adolescents. It involves monitoring sleep patterns and mood while adjusting light exposure (more bright light in the morning; less blue light at night) and managing sleep schedules.
2Treatment groups
Experimental Treatment
Active Control
Group I: Advance/Extend ManipulationExperimental Treatment4 Interventions
For \~2 weeks, Advance/Extend participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days will be instructed to:
* Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed)
* Increase morning bright light exposure via bright light goggles (30 min after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
Group II: ControlActive Control1 Intervention
Control participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 13 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments, thereby controlling for effort.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Western Psychiatric HospitalPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
The effect of chronotherapy on depressive symptoms. Evidence-based practice. [2018]The global prevalence of depression is increasing, along with rates of depression-associated disability and mortality, rendering depressive disorders a major public health issue. Chronotherapy involves a variety of strategies that control exposure to environmental stimuli that influence the biological clock, such as sleep deprivation (SD) or wake therapy (WT), sleep phase advance (SPA), and light and dark therapy (LT, DT). The purpose of this Evidence-Based Practice (EBP) paper is to answer PICOT questions by a review the effectiveness of chronotherapeutics interventions on depressive symptoms with depression and the depressive episode in the course of bipolar disorder. Early studies suggested the effectiveness of LT, SD, and SPA, more recent research has revealed differences in the efficacy of single and combined interventions involving both chronotherapeutic and pharmacological components. This therapy reduced dura-tion of hospitalization, improvement recovery, and reduced for changes in drug prescriptions.
A randomized, controlled trial assessing the acute efficacy of triple chronotherapy in unipolar depression. [2022]Triple chronotherapy (wake night [one night without sleep], sleep phase advance, and early morning bright light exposure) demonstrated rapid efficacy primarily in bipolar depression, but has not been as well studied in unipolar depression. Our primary hypothesis is that triple chronotherapy is associated with a significantly greater Week 1 remission rate compared to the alternative protocol.
Light therapies to improve sleep in intrinsic circadian rhythm sleep disorders and neuro-psychiatric illness: A systematic review and meta-analysis. [2021]Circadian dysregulation causes sleep disturbance and impacts quality of life and functioning. Some interventions target circadian entrainment through modifying light exposure, but existing reviews of light interventions for sleep improvement include few studies in psychiatric populations. We examined effect of light interventions on sleep quality, duration and timing, and effect moderators. We included controlled studies in intrinsic circadian rhythm disorders (such as advanced or delayed sleep) and in neuropsychiatric disorders with assumed high prevalence of circadian dysregulation (such as affective and psychotic disorders). Articles were identified through database searching: 40 studies reporting 49 relevant intervention comparisons met inclusion criteria. Meta-analysis showed improvements in sleep continuity (ES = -0.23, p = 0.000), self-reported sleep disturbance (ES = -0.32, p = 0.014), and advancement of delayed sleep timing (ES = -0.34, p = 0.010). Although the small number of studies limited meta-regression, evening light avoidance was associated with greater increase in total sleep time. Effects of light on sleep and circadian outcomes have received limited attention in studies in psychiatric disorders, but results were promising in these groups. These findings invite further refinement and testing of light interventions to improve sleep in psychiatric disorders, with improved assessment and specification of problems, and the development and implementation of light schedule interventions for delayed sleep.
Morningness-eveningness scores predict outcomes differentially for depressed patients attending morning vs. afternoon day treatment streams. [2020]At the Center for Addiction and Mental Health (CAMH) Integrated Day Treatment (IDT) program, each patient attends either a morning stream or an afternoon stream, but not both. We examined whether subjective chronotype, or the time of day an individual prefers to be most active and alert, predicted treatment outcomes differentially in depressed patients attending the morning vs. afternoon IDT streams. The Horne-Östberg Morningness-Eveningness Questionnaire (MEQ) was administered before IDT treatment to 203 consecutive patients experiencing a major depressive episode. Multiple regression was used to predict change in depression and quality of life scores based on treatment stream (morning or afternoon), baseline MEQ scores and the treatment stream by MEQ interaction. The treatment stream by MEQ interaction was a highly significant predictor of both depression and quality of life change scores. Post-hoc analyses based on established MEQ categories revealed that definite evening chronotypes had significantly better responses in the morning stream than did morning chronotypes, and significantly worse responses in the afternoon stream relative to moderate evening or neutral chronotypes. There were insufficient morning chronotypes in the afternoon stream to assess clinical responses for this subgroup. In the morning stream only, there was a significant positive correlation between the change in MEQ scores after four weeks of IDT treatment (i.e. a shift to greater morningness) and the decrease in depression scores (r = .36, p = .003), consistent with a therapeutic phase advance in circadian rhythms. In sum, these preliminary data suggest that definite evening chronotypes may have the greatest relative benefit from attending the morning vs. afternoon IDT stream. As patients currently select which IDT stream they will attend, future work based on randomized treatment assignment and using passive actigraphy to assess circadian phase is currently planned to extend these preliminary findings.
Adjunctive triple chronotherapy (combined total sleep deprivation, sleep phase advance, and bright light therapy) rapidly improves mood and suicidality in suicidal depressed inpatients: an open label pilot study. [2022]Previous studies have demonstrated that combined total sleep deprivation (Wake therapy), sleep phase advance, and bright light therapy (Triple Chronotherapy) produce a rapid and sustained antidepressant effect in acutely depressed individuals. To date no studies have explored the impact of the intervention on unipolar depressed individuals with acute concurrent suicidality. Participants were suicidal inpatients (N = 10, Mean age = 44 ± 16.4 SD, 6F) with unipolar depression. In addition to standard of care, they received open label Triple Chronotherapy. Participants underwent one night of total sleep deprivation (33-36 h), followed by a three-night sleep phase advance along with four 30-min sessions of bright light therapy (10,000 lux) each morning. Primary outcome measures included the 17 item Hamilton depression scale (HAM17), and the Columbia Suicide Severity Rating Scale (CSSRS), which were recorded at baseline prior to total sleep deprivation, and at protocol completion on day five. Both HAM17, and CSSRS scores were greatly reduced at the conclusion of the protocol. HAM17 scores dropped from a mean of 24.7 ± 4.2 SD at baseline to a mean of 9.4 ± 7.3 SD on day five (p = .002) with six of the ten individuals meeting criteria for remission. CSSRS scores dropped from a mean of 19.5 ± 8.5 SD at baseline to a mean of 7.2 ± 5.5 SD on day five (p = .01). The results of this small pilot trial demonstrate that adjunctive Triple Chronotherapy is feasible and tolerable in acutely suicidal and depressed inpatients. Limitations include a small number of participants, an open label design, and the lack of a comparison group. Randomized controlled studies are needed.
Effect of Morning Light Glasses and Night Short-Wavelength Filter Glasses on Sleep-Wake Rhythmicity in Medical Inpatients. [2020]Sleep and circadian rhythm disorders are common amongst medical inpatients. They are caused by a mixture of factors, including noise, loss of habitual daily routines, and abnormal exposure to light, which tends to be insufficient in the day and too high at night. The aim of the present study was to test the efficacy of morning light therapy plus night short-wavelength filter glasses on sleep quality/timing, and sleepiness/mood over the daytime hours, in a group of well-characterized medical inpatients. Thirty-three inpatients were enrolled and randomized (2:1) to either treatment (n = 22; 13 males, 48.3 ± 13.3 years) or standard of care (n = 11; 8 males, 56.9 ± 12.9 years). On admission, all underwent a baseline assessment of sleep quality/timing and diurnal preference. During hospitalization they underwent monitoring of sleep quality/timing (sleep diaries and actigraphy), plus hourly assessment of sleepiness/mood during the daytime hours on one, standard day of hospitalization. Patients in the treatment arm were administered bright light through glasses immediately after awakening, and wore short-wavelength filter glasses in the evening hours. Treated and untreated patients were comparable in terms of demographics, disease severity/comorbidity, diurnal preference and pre-admission sleep quality/timing. During hospitalization, sleep diaries documented a trend for a lower number of night awakenings in treated compared to untreated patients (1.6 ± 0.8 vs. 2.4 ± 1.3, p = 0.057). Actigraphy documented significantly earlier day mode in treated compared to untreated patients (06:39 ± 00:35 vs. 07:44 ± 00:40, p = 0.008). Sleepiness during a standard day of hospitalization, recorded between 09:30 and 21:30, showed physiological variation in treated compared to untreated patients, who exhibited a more blunted profile. The level of sleepiness reported by treated patients was lower over the 09:30-14:30 interval, i.e., soon after light administration (interaction effect: F = 2.661; p = 0.026). Mood levels were generally higher in treated patients, with statistically significant differences over the 09:30-14:30 time interval, i.e., soon after light administration (treatment: F = 5.692, p = 0.026). In conclusion, treatment with morning bright light and short-wavelength filter glasses in the evening, which was well tolerated, showed positive results in terms of sleepiness/mood over the morning hours and a trend for decreased night awakenings.
Dark therapy for bipolar disorder using amber lenses for blue light blockade. [2022]"Dark Therapy", in which complete darkness is used as a mood stabilizer in bipolar disorder, roughly the converse of light therapy for depression, has support in several preliminary studies. Although data are limited, darkness itself appears to organize and stabilize circadian rhythms. Yet insuring complete darkness from 6 p.m. to 8 a.m. the following morning, as used in several studies thus far, is highly impractical and not accepted by patients. However, recent data on the physiology of human circadian rhythm suggests that "virtual darkness" may be achievable by blocking blue wavelengths of light. A recently discovered retinal photoreceptor, whose fibers connect only to the biological clock region of the hypothalamus, has been shown to respond only to a narrow band of wavelengths around 450 nm. Amber-tinted safety glasses, which block transmission of these wavelengths, have already been shown to preserve normal nocturnal melatonin levels in a light environment which otherwise completely suppresses melatonin production. Therefore it may be possible to influence human circadian rhythms by using these lenses at night to blunt the impact of electrical light, particularly the blue light of ubiquitous television screens, by creating a "virtual darkness". One way to investigate this would be to provide the lenses to patients with severe sleep disturbance of probable circadian origin. A preliminary case series herein demonstrates that some patients with bipolar disorder experience reduced sleep-onset latency with this approach, suggesting a circadian effect. If amber lenses can effectively simulate darkness, a broad range of conditions might respond to this inexpensive therapeutic tool: common forms of insomnia; sleep deprivation in nursing mothers; circadian rhythm disruption in shift workers; and perhaps even rapid cycling bipolar disorder, a difficult- to -treat variation of a common illness.
Light therapy with boxes or glasses to counteract effects of acute sleep deprivation. [2021]Sleep deprivation, in the context of shift work, is an increasing major public health issue. We aimed to determine whether early light administration can counteract sleep deprivation effects, and to compare LED-glasses with a traditional light therapy box. This cross-over design study included 18 individuals exposed to light therapy for 30 minutes at 5 am after one night of complete sleep deprivation, to mimic the night shift condition. Individuals were randomly exposed to 10,000 Lux light box, 2,000 Lux LED blue-enriched glasses, and control (ambient dim-light at 8 lux). Alertness, cognition and mood were assessed throughout the night and following morning. Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation. A rebound was observed at 8 am resulting from the circadian drive overriding cumulative sleep homeostatic effects. Morning light significantly improved sleepiness and sustained attention from 5 to 7 am. These effects were comparable between devices and significantly different from control. Both devices were overall well and similarly tolerated. Early morning light therapy in the condition of sleep loss may have broad practical applications to improve sleepiness, sustained attention and subsequent risk of accidents.
Changing color and intensity of LED lighting across the day impacts on circadian melatonin rhythms and sleep in healthy men. [2021]We examined whether dynamically changing light across a scheduled 16-h waking day influences sleepiness, cognitive performance, visual comfort, melatonin secretion, and sleep under controlled laboratory conditions in healthy men. Fourteen participants underwent a 49-h laboratory protocol in a repeated-measures study design. They spent the first 5 hours in the evening under standard lighting, followed by an 8-h nocturnal sleep episode at habitual bedtimes. Thereafter, volunteers either woke up to static light or to a dynamic light that changed spectrum and intensity across the scheduled 16-h waking day. Following an 8-h nocturnal sleep episode, the volunteers spent another 11 hours either under static or dynamic light. Static light attenuated the evening rise in melatonin levels more compared to dynamic light as indexed by a significant reduction in the melatonin AUC prior to bedtime during static light only. Participants felt less vigilant in the evening during dynamic light. After dynamic light, sleep latency was significantly shorter in both the baseline and treatment night while sleep structure, sleep quality, cognitive performance, and visual comfort did not significantly differ. The study shows that dynamic changes in spectrum and intensity of light promote melatonin secretion and sleep initiation in healthy men.
Circadian genes, rhythms and the biology of mood disorders. [2022]For many years, researchers have suggested that abnormalities in circadian rhythms may underlie the development of mood disorders such as bipolar disorder (BPD), major depression and seasonal affective disorder (SAD). Furthermore, some of the treatments that are currently employed to treat mood disorders are thought to act by shifting or "resetting" the circadian clock, including total sleep deprivation (TSD) and bright light therapy. There is also reason to suspect that many of the mood stabilizers and antidepressants used to treat these disorders may derive at least some of their therapeutic efficacy by affecting the circadian clock. Recent genetic, molecular and behavioral studies implicate individual genes that make up the clock in mood regulation. As well, important functions of these genes in brain regions and neurotransmitter systems associated with mood regulation are becoming apparent. In this review, the evidence linking circadian rhythms and mood disorders, and what is known about the underlying biology of this association, is presented.
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.