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

Trial Summary

What is the purpose of this trial?

There is strong reason to believe that sleep promotion during adolescence could yield long-term health rewards; the investigators' data show that, when they get more sleep, Morning Larks have impressively reduced intake of overall calories and foods high in glycemic load that are linked to long-term health risk. Before that can be translated into major public health interventions, however, the field needs to understand why similar changes in sleep had no effect, or even an adverse effect, on adolescent Night Owls. This experimental study will clarify why there have been such discrepant effects across Morning Larks and Night Owls, with the goal of more broadly harnessing the promise of improved sleep in the prevention of obesity and long-term morbidity.

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 data supports the effectiveness of the treatment Sleep Extension for Circadian Rhythm Disorder?

Research on similar treatments like melatonin and light therapy for circadian rhythm disorders shows that these can help adjust sleep patterns, although results vary. Melatonin has been shown to help people fall asleep earlier, and light therapy can improve sleepiness and cognitive function when combined with melatonin. ^{1 2 3 4 5}

How does the Sleep Extension treatment differ from other treatments for circadian rhythm disorders?

Sleep Extension treatment is unique because it focuses on extending sleep duration either early or late, which is different from other common treatments like light therapy and melatonin that aim to shift the sleep phase. This approach may help align the sleep-wake cycle with the body's natural circadian rhythm by promoting longer sleep periods. ^{2 6 7 8 9}

Research Team

Dean W Beebe, PhD

Principal Investigator

Cincinnati Children's

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced evening light for advanced sleep phase syndrome. [2015]

2. France pubmed.ncbi.nlm.nih.gov

[Delayed wakefulness-sleep rhythm syndrome and melatonin. Synthesis of existing studies]. [2013]

3. United States 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. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Melatonin and delayed sleep phase syndrome: ambulatory polygraphic evaluation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating the role of melatonin in the long-term treatment of delayed sleep phase syndrome (DSPS). [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

[Diagnosis and treatment in circadian rhythm sleep disorders]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

A practical approach to circadian rhythm sleep disorders. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Light treatment for sleep disorders: consensus report. IV. Sleep phase and duration disturbances. [2017]

9. Turkey pubmed.ncbi.nlm.nih.gov

[Delayed sleep phase type sleep disorder and chronotherapy]. [2009]