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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand delayed sleep-wake phase disorder (DSWPD), a condition where individuals struggle to fall asleep and wake up at regular times. Researchers seek to determine if people with DSWPD have different circadian rhythms and how they respond to light compared to those without the disorder. They are also testing a new method to predict sleep patterns from a blood test. Individuals living at high altitudes, such as Denver, and diagnosed with DSWPD might be suitable candidates. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research that could enhance the understanding and treatment of DSWPD.

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 prior data suggests that these assessments are safe?

Research shows that people with delayed sleep–wake phase disorder (DSWPD) often have increased sensitivity to light. Their bodies react strongly to changes in light, affecting sleep patterns. The study under consideration aims to better understand these reactions. The tests used to measure body clocks and light sensitivity are non-invasive, meaning they don't involve any procedures inside the body, ensuring safety. Participants in previous studies generally handled these tests well, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand Delayed Sleep Phase Syndrome (DSPS) by assessing circadian rhythms and light sensitivity, which are not typically the focus of current treatments. Most treatments for DSPS, like melatonin supplements or light therapy, primarily address symptoms rather than exploring the underlying causes. This trial could reveal new insights into how individual circadian rhythms and light sensitivity contribute to DSPS, potentially leading to more personalized and effective treatment strategies in the future.

What evidence suggests that this method is effective for assessing delayed sleep phase syndrome?

Research shows that people with Delayed Sleep Phase Syndrome (DSWPD) are more sensitive to light, which can delay their sleep schedule. This trial will assess circadian rhythms and light sensitivity to better understand these effects. Studies have found that a test called dim light melatonin onset (DLMO) accurately identifies these sleep issues. This test checks when the body starts preparing for sleep and reliably identifies the disorder with a 90.3% accuracy rate and rules it out with an 84.0% accuracy rate when not present. Additionally, people with DSWPD often have inconsistent sleep patterns, impacting their sleep quality. These assessments help researchers understand how light affects sleep and assist in diagnosing sleep disorders related to the body's natural sleep/wake cycle. ^{1 3 6 7 8}

Who Is on the Research Team?

Kenneth Wright, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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 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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6292803/

Increased sensitivity of the circadian system to light in ...

Patients with delayed sleep–wake phase disorder (DSWPD) demonstrate greater sensitivity of the circadian system to the phase‐delaying effects of light.

2.

nature.com

nature.com/articles/s41598-021-89924-8

Light-based methods for predicting circadian phase in ...

This study evaluated two methods for predicting dim light melatonin onset (DLMO) in 154 DSWPD patients using ~ 7 days of sleep–wake and light data.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1389945708001494

Clinical efficacy of dim light melatonin onset testing in ...

The DLMO test is an accurate tool for differentiating between sleep disorder patients with or without underlying circadian rhythm disruption. It is effective ...

4.

jcsm.aasm.org

jcsm.aasm.org/doi/10.5664/jcsm.8516

Sleep and circadian instability in delayed sleep-wake phase ...

We find that circadian timing is less stable and sleep is less regular in patients with DSWPD, which could contribute to etiology of the disorder.

5.

withpower.com

withpower.com/trial/phase-sleep-disorders-circadian-rhythm-3-2024-9d356

Assessments for Delayed Sleep Phase Syndrome

The Dim Light Melatonin Onset (DLMO) test demonstrated high clinical sensitivity (90.3%) and specificity (84.0%) for diagnosing Delayed Sleep Phase Syndrome ( ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00246454

Circadian Rhythms and Sleep in Familial DSPS and ASPS

The purpose of this study is to determine the properties of circadian rhythms and sleep propensity in familial advanced and delayed sleep phase syndrome (DSPS).

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1071909123000608

Current Considerations in the Diagnosis and Treatment of ...

Sleep logs and actigraphy over 7+ days typically demonstrate a delayed sleep onset and sleep offset usually greater than 2 hours relative to times that are ...

8.

aasm.org

aasm.org/wp-content/uploads/2022/05/ICSD-3-TR-CRSWD-Draft.pdf

Circadian Rhythm Sleep-Wake Disorders

Circadian rhythms are endogenous, near-24-hour biological rhythms that exist in all living organisms. The internal near-24-hour circadian timekeeping system ...