Glasses for Adolescent Delayed Sleep-Wake Phase Disorder

NCT04378933 | Completed Results FDA Device

• 1 other identifier: 18-003036
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if evening amber glasses combined with stable wake times will show an increase in total sleep time (TST) and an advance in sleep onset times (shift earlier) compared to the control group.

Conditions

Delayed Sleep-Wake Phase Disorder

Outcome Measures

Primary Outcomes (4)

• Change in School Night Sleep Onset Time

  The time in hours that sleep onset time shifted earlier during school nights. Measured by self-reporting logs and a wrist actigraphy that detects when subjects are active or sleeping.

  baseline, week 3

• Change in Non-school Night Sleep Onset Time

  The time in hours that sleep onset time shifted earlier during non-school nights. Measured by self-reporting logs and a wrist actigraphy that detects when subjects are active or sleeping.

  baseline, week 3

• Change in Dim Light Melatonin Onset (DLMO)

  The time of day the subject feels sleepy during the overnight lab stays. It is a marker of biological time. Data are provided in decimal and military time (e.g., 10:00 pm equals 22.00). Using a light lux meter, the lighting in the room was limited to no more than 5 lux of light. Measured by self-reported logs and a wrist actigraphy that detects when subjects are active or sleeping.

  baseline, week 3

• Change in Dim Light Melatonin Onset (DLMO) Phase Shift

  The time in hours the circadian clock shifted the sleep onset time. Using a light lux meter, the lighting in the room will be limited to no more than 5 lux of light. Measured by self-reported logs and a wrist actigraphy that detects when subjects are active or sleeping.

  baseline, week 2

Study Arms (2)

Amber Glasses and Fixed Wake

EXPERIMENTAL

Participants will wear glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use is reached. Participants will also be required to wake up at the same time (±30 mins).

Device: Amber Glasses

Clear glasses and Free Wake

ACTIVE COMPARATOR

Participants will wear identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use is reached. Participants will not be given instructions regarding sleep schedule.

Device: Clear Lens Glasses

Interventions

Amber Glasses DEVICE

Half of the participants will be wearing the amber glasses to see if they can help with sleep onset.

Amber Glasses and Fixed Wake

Clear Lens Glasses DEVICE

Half of the participants will be wearing the clear glasses to see if the glasses help with sleep onset.

Clear glasses and Free Wake

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Regular school attendance in the setting of a fixed start time.
• Adherence to ICSD-3 DSWPD diagnostic criteria.
• Average spontaneous weekend wake time ≥1 hour than school day wake time.
• Initiation of school-night sleep at 12 a.m. or later, ≥50% of the time, during a 14-day period (items 3-4 to be determined by sleep logs and actigraphy). As there are no discrete clock times associated with the ICSD-3 DSWPD description, this cutoff is based on data obtained from the 2006 Sleep in America Poll and experiences gleaned from prior recruitment.

You may not qualify if:

• A positive urine drug abuse screen will disqualify the individual from further participation.
• Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.
• Alcohol and nicotine use will also be screened to qualify for the study. We will also screen for alcohol immediately before each DLMO assessment because alcohol acutely suppresses melatonin.
• Patients receiving medications that might contribute to sleep disturbances and/or affect treatment responses will be considered ineligible (e.g., hypnotics, antidepressants, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs), beta blockers).
• All subjects will be asked to refrain from caffeine use on the days of phase assessments, and to cease ingestion at least 6 hours prior to nightly bedtime.
• The Ishihara Color Blindness Test will be done and patients who are color blind/deficient will be disqualified from participating in the study.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Results Point of Contact

• Title: R. Robert Auger, M.D.
• Organization: Mayo Clinic

Auger.Raymond1@mayo.edu

507-266-1066

Study Officials

• R. Robert Auger, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: February 27, 2019
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)