Delayed Sleep-Wake Phase DisorderNCT04378933
Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
A study testing Amber Glasses and Clear Lens Glasses in people with Delayed Sleep-Wake Phase Disorder, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Sleep-Wake Phase Disorder
- What is being tested?
- Amber Glasses and Clear Lens Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2019to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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- Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Glasses for Adolescent Delayed Sleep-Wake Phase Disorder (GLAD)
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.
Read the detailed description
We propose a 3-week field study that examines the efficacy, acceptance, and compliance of using evening amber glasses to block evening light combined with a stable wake time in adolescents (14-17 years) with DSWPD (International Classification of Sleep Disorders [ICSD-3] criteria).3 After 1 week of baseline measurements, subjects will be instructed to wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before individually calculated midsleep time measured during the preceding week. This corresponds to the time when adolescents are most sensitive to phase delaying light according to Co-I Crowley's recently published phase response curve (PRC) to light in adolescents (Figure 1).22 This "amber glasses + stable wake time" group will be compared to a control group: adolescent DSWPD patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach the eyes, otherwise identical in appearance) in the evening at the same times as the alternate group, but without scheduled wake times. Outcome measures will include TST and sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary DLMO, and assessments of acceptance and compliance.
- Conditions
- Delayed Sleep-Wake Phase Disorder
- Being tested
- Amber Glasses, Clear Lens Glasses
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amber GlassesDevice
Half of the participants will be wearing the amber glasses to see if they can help with sleep onset.
Clear Lens GlassesDevice
Half of the participants will be wearing the clear glasses to see if the glasses help with sleep onset.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Clear Lens Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start27 Feb 2019
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Delayed Sleep-Wake Phase DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Robert Auger, Mayo Clinic
- Investigators
- R. Robert Auger, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378933
- Sponsor's protocol ID
- 18-003036
- Status last verified
- May 2023
- First submitted
- 5 May 2020
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glasses for Adolescent Delayed Sleep-Wake Phase Disorder (GLAD)
- ClinicalTrials.gov ID
- NCT04378933
- Acronym / sponsor ID
- 18-003036
- Conditions
- Delayed Sleep-Wake Phase Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We propose a 3-week field study that examines the efficacy, acceptance, and compliance of using evening amber glasses to block evening light combined with a stable wake time in adolescents (14-17 years) with DSWPD (International Classification of Sleep Disorders [ICSD-3] criteria).3 After 1 week of baseline measurements, subjects will be instructed to wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before individually calculated midsleep time measured during the preceding week. This corresponds to the time when adolescents are most sensitive to phase delaying light according to Co-I Crowley's recently published phase response curve (PRC) to light in adolescents (Figure 1).22 This "amber glasses + stable wake time" group will be compared to a control group: adolescent DSWPD patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach the eyes, otherwise identical in appearance) in the evening at the same times as the alternate group, but without scheduled wake times. Outcome measures will include TST and sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary DLMO, and assessments of acceptance and compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amber Glasses and Fixed Wake | Experimental | Device: Amber GlassesParticipants 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). |
| Clear glasses and Free Wake | Active comparator | Device: Clear Lens GlassesParticipants 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amber GlassesHalf of the participants will be wearing the amber glasses to see if they can help with sleep onset. | Device | Amber Glasses and Fixed Wake |
| Clear Lens GlassesHalf of the participants will be wearing the clear glasses to see if the glasses help with sleep onset. | Device | Clear glasses and Free Wake |
Primary outcome
Change in School Night Sleep Onset Time
Time frame: baseline, week 3
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.
Change in Non-school Night Sleep Onset Time
Time frame: baseline, week 3
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.
Change in Dim Light Melatonin Onset (DLMO)
Time frame: baseline, week 3
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.
Change in Dim Light Melatonin Onset (DLMO) Phase Shift
Time frame: baseline, week 2
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Robert Auger, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amber Glasses and Clear Lens Glasses in people with Delayed Sleep-Wake Phase Disorder, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in School Night Sleep Onset Time (time frame: baseline, week 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.