Assessments for Delayed Sleep Phase Syndrome

Recruiting at 1 trial location

Overseen By Kenneth Wright, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Boulder

Must not be taking: Medication use

Disqualifiers: Recent medical condition, Psychiatric disorder, Sleep disorder, others

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

Compensation: Varies

Number of Visits: 5

66 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, participants must stop taking their current medications, as medication use is listed as an exclusion criterion for this trial.

What data supports the effectiveness of this treatment for Delayed Sleep Phase Syndrome?

Research shows that bright light therapy and melatonin can help people with Delayed Sleep Phase Syndrome by improving sleepiness, fatigue, and cognitive function. Bright light exposure in the morning can adjust the body's internal clock, making it easier to fall asleep and wake up at desired times. ^{1 2 3 4 5}

Is the treatment for Delayed Sleep Phase Syndrome safe for humans?

Melatonin, used for circadian rhythm disorders, has low short-term toxicity but lacks long-term safety data. It should be used carefully, as incorrect timing can cause negative effects, and unlicensed preparations are not recommended. ^{3 6 7 8 9}

How does the treatment for Delayed Sleep Phase Syndrome using circadian rhythm and light sensitivity assessments differ from other treatments?

This treatment is unique because it focuses on assessing the body's internal clock and sensitivity to light, rather than just addressing sleep/wake cycle disruptions. It uses specific tests like the Dim Light Melatonin Onset (DLMO) to diagnose and guide treatment, which is different from standard treatments that often involve planned sleep schedules or timed light exposure. ^{4 10 11 12 13}

What is the purpose of this trial?

The goal of this study is to understand factors that contribute to delayed sleep wake phase disorder (DSWPD). The investigators will examine whether patients with DSWPD exhibit alterations in circadian rhythms and sensitivity to light compared to healthy controls. The investigators will also test a new method of predicting circadian rhythms form a blood sample.

Research Team

Kenneth Wright, PhD

Principal Investigator

University of Colorado, Boulder

Eligibility Criteria

This trial is for individuals diagnosed with delayed sleep wake phase disorder (DSWPD), living at high altitudes like Denver or higher, and have a body mass index (BMI) that's normal to moderately overweight. It excludes those with psychiatric disorders, other sleep disorders, current medication use, or recent medical conditions.

Inclusion Criteria

Altitude history: currently residing at Denver altitude or higher

BMI normal to moderately overweight

I have been diagnosed with delayed sleep wake phase disorder.

Exclusion Criteria

Recent medical condition

Psychiatric disorder

I have a diagnosed sleep disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Ambulatory Monitoring

Participants undergo 1-2 weeks of ambulatory monitoring at home, including wearing a blood sugar monitor and tracking sleep and eating patterns.

3 weeks

2 visits (in-person) for equipment pickup

Laboratory Stay 1

Participants spend 66 hours in the laboratory under controlled conditions, including dim light exposure, frequent saliva and blood sampling, and cognitive testing.

2.75 days

1 visit (in-person)

Home Sleep

Participants sleep normally at home for approximately 2 weeks, followed by 1 week of additional ambulatory monitoring.

3 weeks

Laboratory Stay 2

Participants spend 48 hours in the laboratory with exposure to different light levels, frequent saliva sampling, and cognitive testing.

2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the laboratory stays.

4 weeks

Treatment Details

Interventions

• Circadian rhythm assessment
• Light sensitivity assessment

Trial Overview The study aims to understand DSWPD by comparing circadian rhythms and light sensitivity in patients versus healthy controls. Additionally, it will evaluate a new blood test method designed to predict circadian rhythms.

Participant Groups

Group I: Assessment Experimental Treatment 2 Interventions

Circadian rhythms and light sensitivity

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

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 involving 20 patients with delayed sleep phase syndrome (DSPS), exposure to 2 hours of bright light in the morning effectively advanced their circadian rhythms, helping them fall asleep earlier and stay alert in the morning.

The results highlight the critical role of light in regulating human circadian rhythms, demonstrating that morning light exposure combined with evening light restriction can significantly improve sleep patterns in individuals with DSPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase-shifting effects of bright morning light as treatment for delayed sleep phase syndrome. Rosenthal, NE., Joseph-Vanderpool, JR., Levendosky, AA., et al.[2022]

In a 14-day home study involving 44 participants aged 16-26 with delayed sleep phase disorder, light therapy significantly improved both sleep onset and sleep offset times.

The effectiveness of light therapy was positively influenced by the number of days the therapy lamp was used, indicating that consistent use is key for better sleep outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light Therapy With Scheduled Rise Times in Young Adults With Delayed Sleep Phase Disorder: Therapeutic Outcomes and Possible Predictors. Danielsson, K., Jansson-Fröjmark, M., Broman, JE., et al.[2018]

The Dim Light Melatonin Onset (DLMO) test demonstrated high clinical sensitivity (90.3%) and specificity (84.0%) for diagnosing Delayed Sleep Phase Syndrome (DSPS) in a study of 56 patients, indicating its effectiveness in identifying this condition.

Patients with DSPS showed a significant delay in melatonin secretion onset, confirming that the DLMO test can accurately reflect underlying circadian rhythm disruptions associated with the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of dim light melatonin onset testing in diagnosing delayed sleep phase syndrome. Rahman, SA., Kayumov, L., Tchmoutina, EA., et al.[2022]

In a study involving three patients with delayed sleep phase syndrome (DSPS) and seven healthy controls, it was found that DSPS patients showed significant differences in sleep propensity compared to controls after 24 hours of sleep deprivation.

Unlike healthy individuals, DSPS patients did not experience recovery sleep during the subjective day when melatonin levels were low, indicating potential issues with sleep regulation and homeostasis in DSPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poor recovery sleep after sleep deprivation in delayed sleep phase syndrome. Uchiyama, M., Okawa, M., Shibui, K., et al.[2015]

Adolescents with delayed sleep phase disorder (DSPD) experience more evening light exposure and less morning light compared to unaffected controls, which may contribute to their sleep timing issues.

The study found that increased total sleep time is linked to decreased evening and morning light exposure, suggesting that managing light exposure could help improve sleep patterns in adolescents with DSPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light exposure among adolescents with delayed sleep phase disorder: a prospective cohort study. Auger, RR., Burgess, HJ., Dierkhising, RA., et al.[2021]

The study compared the effectiveness of two questionnaires, the Morningness-Eveningness Questionnaire (MEQ) and the Munich ChronoType Questionnaire (MCTQ), in estimating the dim light melatonin onset (DLMO), a key measure of circadian timing, using a sample of 60 participants (36 healthy controls and 24 with delayed sleep phase disorder).

Both questionnaires showed significant correlation with DLMO, but neither should be used alone for timing light or melatonin treatments due to a potential 4-hour variability in DLMO estimates, which could lead to circadian misalignment if treatments are mistimed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Morningness-Eveningness Questionnaire and Munich ChronoType Questionnaire to the Dim Light Melatonin Onset. Kantermann, T., Sung, H., Burgess, HJ.[2022]

Melatonin can effectively improve sleep and adjust circadian rhythms when taken at the right times, helping with issues like jet lag and shift work, but its effectiveness is closely related to the timing and dosage.

While melatonin is generally safe for short-term use in healthy adults, there is a lack of long-term safety data, and its use should be carefully managed to avoid potential negative effects, especially with unregulated preparations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of circadian rhythm disorders--melatonin. Arendt, J., Deacon, S.[2019]

Breast cancer survivors were classified into three groups based on their symptoms of fatigue, insomnia, and depression, with 21% experiencing high symptom burden, which was often persistent over time.

Survivors with a late chronotype or low circadian amplitude were more likely to have moderate to high symptom burdens, suggesting that these circadian factors could be targeted in future interventions to help alleviate symptoms in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of circadian parameters and the clustering of fatigue, depression, and sleep problems in breast cancer survivors: a latent class analysis. de Rooij, BH., Ramsey, I., Clouth, FJ., et al.[2023]

A new home saliva collection kit for measuring dim light melatonin onset (DLMO) was tested on 32 participants with delayed sleep phase disorder (DSPD) and showed that 83% of home DLMOs were accurate, unaffected by light or timing errors.

The home DLMOs were found to be highly correlated with laboratory DLMOs, occurring on average just 10.2 minutes earlier, suggesting that this method can reliably assist in diagnosing circadian rhythm sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home dim light melatonin onsets with measures of compliance in delayed sleep phase disorder. Burgess, HJ., Park, M., Wyatt, JK., et al.[2018]

The American Academy of Sleep Medicine has developed comprehensive guidelines for assessing and treating circadian rhythm sleep disorders (CRSDs), emphasizing the use of sleep logs and actigraphy for diagnosis, while polysomnography is not routinely needed unless to rule out other sleep disorders.

Therapeutic interventions for CRSDs include planned sleep schedules, timed light exposure, and melatonin administration, with specific recommendations for conditions like shift work disorder and jet lag, highlighting the importance of tailored treatment approaches based on individual disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. An American Academy of Sleep Medicine report. Morgenthaler, TI., Lee-Chiong, T., Alessi, C., et al.[2022]

A study involving 54 volunteers with delayed sleep phase syndrome (DSPS) showed that using a bright light mask significantly advanced their circadian rhythms and sleep onset times compared to a dim light placebo.

Participants with more severe circadian delays experienced the most benefit from the bright light treatment, reporting it as more effective, and the treatment was well tolerated with minimal sleep disturbance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright-light mask treatment of delayed sleep phase syndrome. Cole, RJ., Smith, JS., Alcalá, YC., et al.[2017]

Self-reported sleep timing can effectively predict the circadian phase in individuals with Delayed Sleep Wake Phase Disorder (DSWPD), which is crucial for guiding light and melatonin treatments.

In a study of 24 participants, combining various self-reported sleep measures allowed for accurate estimation of the circadian phase within ±1.5 hours for 88% of the sample, indicating a practical and cost-effective approach for clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the circadian phase be estimated from self-reported sleep timing in patients with Delayed Sleep Wake Phase Disorder to guide timing of chronobiologic treatment? Lovato, N., Micic, G., Gradisar, M., et al.[2018]

References

1. 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]

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

Phase-shifting effects of bright morning light as treatment for delayed sleep phase syndrome. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Light Therapy With Scheduled Rise Times in Young Adults With Delayed Sleep Phase Disorder: Therapeutic Outcomes and Possible Predictors. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical efficacy of dim light melatonin onset testing in diagnosing delayed sleep phase syndrome. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Poor recovery sleep after sleep deprivation in delayed sleep phase syndrome. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Light exposure among adolescents with delayed sleep phase disorder: a prospective cohort study. [2021]

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

Comparing the Morningness-Eveningness Questionnaire and Munich ChronoType Questionnaire to the Dim Light Melatonin Onset. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of circadian rhythm disorders--melatonin. [2019]

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

The association of circadian parameters and the clustering of fatigue, depression, and sleep problems in breast cancer survivors: a latent class analysis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Home dim light melatonin onsets with measures of compliance in delayed sleep phase disorder. [2018]

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

Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. An American Academy of Sleep Medicine report. [2022]

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

Bright-light mask treatment of delayed sleep phase syndrome. [2017]

13. England pubmed.ncbi.nlm.nih.gov

Can the circadian phase be estimated from self-reported sleep timing in patients with Delayed Sleep Wake Phase Disorder to guide timing of chronobiologic treatment? [2018]