Sleep Extension for Circadian Rhythm Disorder

(STEAM Trial)

Overseen By Caroline Wall, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Psychiatric medications

Disqualifiers: Obesity, Insomnia, Neurologic illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how extending sleep affects teenagers' eating habits and long-term health, focusing on those who are naturally early risers (Morning Larks) versus those who prefer staying up late (Night Owls). Participants will either align their sleep schedule with their natural rhythm or misalign it, such as a Morning Lark sleeping in later or a Night Owl going to bed earlier. The goal is to understand why extra sleep helps some teens reduce unhealthy eating but not others. The study seeks healthy teens aged 14-18 who do not have conditions like obesity or sleep-related disorders and can adjust their sleep schedule as required. As an unphased trial, this study offers teens a unique opportunity to contribute to research that could improve sleep and health outcomes for their peers.

Will I have to stop taking my current medications?

If you are taking psychiatric medications or other drugs that affect sleep, weight, or dietary behaviors, you will need to stop taking them to participate in this trial.

What prior data suggests that this sleep extension protocol is safe for adolescents?

Research has shown that getting more sleep can improve focus and energy levels. For instance, one study found that when people slept more, they paid better attention and made fewer mistakes on tasks requiring concentration. This suggests that the treatment is generally easy for people to handle.

Regarding energy and diet, another study found that sleeping more helped adults eat less, leading to lower calorie consumption. This is a positive sign, indicating no harmful effects from increased sleep.

Evidence also suggests that sleeping more does not cause negative effects, even over a long period. Studies have not linked more sleep to any adverse outcomes in controlled settings.

Overall, current research suggests that getting more sleep is safe and may offer benefits like better focus and reduced calorie intake, without any known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how extending sleep duration can realign or misalign with an individual’s natural circadian rhythm to improve circadian rhythm disorders. Unlike standard treatments, which often involve light therapy or melatonin supplements, this approach focuses on adjusting sleep timing to match or oppose a person’s natural sleep-wake cycle. The Circadian-Aligned Sleep Extension aims to enhance well-being by syncing with a participant's natural sleep pattern, while the Circadian-Misaligned Sleep Extension tests the impact of altering this pattern. This trial could reveal how personalized sleep adjustments might offer a new avenue for managing circadian disruptions, offering insights beyond conventional methods.

What evidence suggests that this trial's sleep extension treatments could be effective for circadian rhythm disorder?

This trial will compare two approaches to sleep extension for circadian rhythm disorder. Studies have shown that aligning sleep with one's natural pattern can improve sleep quality and reduce insomnia. Participants in the "Circadian-Aligned Sleep Extension" arm, where sleep extends to match their natural rhythm, may experience better sleep outcomes, such as less insomnia. In contrast, the "Circadian-Misaligned Sleep Extension" arm involves extending sleep in a way that does not align with a person's natural cycle—such as asking someone who stays up late to go to bed earlier. Research indicates that this type of sleep extension can increase total sleep time but may not always align with the body's internal clock. Overall, getting more sleep can be beneficial, but the results depend on whether the extra sleep aligns with one's natural sleep pattern. ^{6 7 8 9 10}

Who Is on the Research Team?

Dean W Beebe, PhD

Principal Investigator

Cincinnati Children's

Are You a Good Fit for This Trial?

Healthy adolescents aged 14-18 can join this study on sleep and eating habits. It's not for those who are obese, take psychiatric drugs, have intellectual disabilities, insomnia, or other sleep disorders. Participants need a flexible schedule that allows early bedtimes and late wake-ups.

Inclusion Criteria

I am a healthy teenager between 14 and 18 years old.

Exclusion Criteria

I am taking medication that affects my sleep, weight, or eating habits.

I have a neurological condition, have had seizures, or a serious head injury.

Work or other obligations that require bedtime later than 9:30 pm or waking prior to 10 am (earliest bedtime and latest rise time possible during sleep extension) during the final week of the study, or other scheduling obligations that preclude participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo periods of sleep restriction and sleep extension, with extension periods randomly assigned to be aligned or misaligned relative to chronotype

3 weeks

Multiple visits for dietary recall interviews

Follow-up

Participants are monitored for dietary intake and glycemic load after the sleep extension period

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Extension (Early)
• Sleep Extension (Late)

Trial Overview The study tests how extending sleep at different times (early night vs. late night) affects eating habits and long-term health in teens known as 'Morning Larks' and 'Night Owls'. The goal is to understand the impact of sleep changes on obesity prevention.

How Is the Trial Designed?

Group I: Circadian-Misaligned Sleep Extension Experimental Treatment 2 Interventions

A sleep extension period that does not conform to a given participant's circadian phase. In other words, this condition asks Morning Larks to extend their sleep by sleeping in later, or asks Night Owls to extend their sleep by going to bed earlier.

Group II: Circadian-Aligned Sleep Extension Experimental Treatment 2 Interventions

A sleep extension period that roughly conforms to a given participant's circadian phase (i.e., fits the schedule of a Morning Lark vs. Night Owl).

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

Published Research Related to This Trial

In a study of six patients with delayed sleep phase syndrome (DSPS), a daily dose of 5 mg melatonin advanced sleep onset by an average of 115 minutes and final awakening by 106 minutes after one month of treatment.

The study confirmed that melatonin effectively shifts sleep-wake rhythms without significantly altering sleep architecture, supporting previous subjective reports of its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin and delayed sleep phase syndrome: ambulatory polygraphic evaluation. Oldani, A., Ferini-Strambi, L., Zucconi, M., et al.[2019]

Chronotherapy and phototherapy can help train the circadian system in patients with delayed sleep phase syndrome, but the effectiveness of these treatments varies based on individual motivation and psychological factors.

Exogenous melatonin has a moderate effect on sleep time in delayed sleep phase syndrome, influencing the body's natural secretion rhythms, but more research is needed to fully understand its potential as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Delayed wakefulness-sleep rhythm syndrome and melatonin. Synthesis of existing studies]. Quera Salva, MA., Lainey, E., Léger, D., et al.[2013]

In a study of 61 patients with Delayed Sleep Phase Syndrome (DSPS), 96.7% reported that a 6-week treatment with 5 mg of melatonin taken daily at 10 PM was helpful, with minimal side effects.

Despite the effectiveness of melatonin, 91.5% of participants experienced a relapse to their original sleep patterns within a year after treatment, indicating that while melatonin can improve sleep timing, long-term effects may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the role of melatonin in the long-term treatment of delayed sleep phase syndrome (DSPS). Dagan, Y., Yovel, I., Hallis, D., et al.[2019]

Bright light treatment and exogenous melatonin are effective treatments for various circadian rhythm sleep disorders, but their success depends on correctly timing the interventions based on the patient's circadian phase.

The review emphasizes the importance of estimating circadian phase through patient history rather than complex measurements, to optimize treatment timing and improve outcomes for disorders like delayed sleep phase and shift work disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical approach to circadian rhythm sleep disorders. Bjorvatn, B., Pallesen, S.[2022]

In a study involving 47 older adults with Advanced Sleep Phase Syndrome, enhanced evening light therapy (approximately 265 lux) was found to be no more effective than a placebo dim light (approximately 2 lux) in objectively improving sleep patterns.

Despite the lack of significant objective benefits, participants receiving the enhanced light reported subjective improvements and a notable delay in sleep onset, indicating potential personal benefits even if not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced evening light for advanced sleep phase syndrome. Palmer, CR., Kripke, DF., Savage, HC., et al.[2015]

In a study involving adolescents and young adults with Delayed Sleep Phase Disorder (DSPD), both bright light and melatonin treatments, along with gradually advanced rise times, effectively improved subjective daytime sleepiness, fatigue, and cognitive function over a short-term period of 2 weeks.

Long-term treatment (3 months) with combined bright light and melatonin further enhanced these benefits, while the no-treatment group reverted to baseline levels, indicating that ongoing treatment is necessary to sustain improvements in sleep and cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial with bright light and melatonin for the treatment of delayed sleep phase disorder: effects on subjective and objective sleepiness and cognitive function. Wilhelmsen-Langeland, A., Saxvig, IW., Pallesen, S., et al.[2013]

Artificial bright light exposure can effectively treat advanced and delayed sleep phase disorders, as well as hypersomnia associated with winter depression, by helping to reset circadian rhythms.

The timing of light exposure is crucial for correcting sleep patterns, with early light exposure promoting phase delays and late exposure facilitating phase advances, although the timing may be less critical for alleviating winter depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light treatment for sleep disorders: consensus report. IV. Sleep phase and duration disturbances. Terman, M., Lewy, AJ., Dijk, DJ., et al.[2017]

Circadian rhythm sleep disorders (CRSD) occur when there is a mismatch between a person's natural sleep patterns and their desired sleep times, often due to disruptions in the body's internal clock located in the brain.

Effective treatments for CRSD include light therapy and melatonin supplements, particularly for those with delayed sleep phase disorder, along with proper sleep hygiene practices that consider the light environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis and treatment in circadian rhythm sleep disorders]. Murakami, J., Imai, M., Yamada, N.[2013]

Chronotherapy, a behavioral technique that involves systematically delaying sleep time, can be an effective treatment for individuals with delayed sleep phase-type sleep disorder, as demonstrated in a case study of a 48-year-old woman.

This disorder leads to symptoms like sleep-onset insomnia and difficulty waking up, and various treatment options, including light therapy and melatonin, are available to help manage these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Delayed sleep phase type sleep disorder and chronotherapy]. Gökben Hizli, F., Yücel Ağargün, M.[2009]

Citations

1. withpower.com withpower.com/trial/phase-chronobiology-disorders-6-2021-1a885

Sleep Extension for Circadian Rhythm Disorder What data supports the effectiveness of the treatment Sleep Extension for Circadian Rhythm Disorder? Research on similar treatments like melatonin and light ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12477115/

Changes in circadian timing following a 1-week in-home ... This study fills a gap in the existing literature by assessing both sleep and circadian rhythms following in-home sleep extension in habitually short-sleeping ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9532314/

Effect of early intervention for anxiety on sleep outcomes in ... Adolescents reported reduced insomnia (odds ratio (OR) = 0.42, p < 0.001) and shorter sleep onset latency (d = 0.27, p < 0.001) from pre- to post-intervention.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70088

Efficacy of a Transdiagnostic Sleep and Circadian ... The intervention group statistically significantly improved sleep quality (p < 0.001), reduced insomnia severity (p < 0.001), and increased well ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079221001179

Behavioral interventions to extend sleep duration The goal of this study was to examine the effects of behavioral sleep extension interventions on sleep duration outcomes in children and adults ≥ age 12.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2679862/

A Clinical Approach to Circadian Rhythm Sleep Disorders - PMC This review will focus on the clinical approach to the diagnosis and management of the various circadian rhythm sleep disorders.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04992611

Sleep Timing, Eating and Activity Measurement Study The Early Sleep Extension condition does so by keeping bedtime the same as the sleep restriction period, but extending sleep by rising later. This produces a ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923011790

Review Circadian Rhythm Sleep–Wake Disorders Modafinil and armodafinil are both approved by the FDA for excessive sleepiness in SWD. Armodafinil benefits objective sleepiness [101] and performance, as well ...

9. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7734

Workplace Interventions to Promote Sleep Health and an Alert ... The purpose of this review is to synthesize the published literature that addresses employer-initiated interventions to improve the sleep of workers.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9886819/

Treatment of Circadian Rhythm Sleep–Wake Disorders - PMC Common treatments for CRSWD currently include sleep health education, time therapy, light therapy, melatonin, and hypnotic drug therapy.