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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amber Glasses | Device | Half of the participants will be wearing the amber glasses to see if they can help with sleep onset. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| R. Robert Auger, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amber Glasses and Fixed Wake | Participants wore 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 was reached. Participants were also required to wake up at the same time (±30 mins). Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset. |
| FG001 | Clear Glasses and Free Wake | Participants wore 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 was reached. Participants were given instructions regarding sleep schedule. Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amber Glasses and Fixed Wake | Participants wore 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 was reached. Participants were also required to wake up at the same time (±30 mins). Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm | Posted | Mean | Standard Deviation | hours | baseline, week 3 |
|
Adverse Events were collected for each subject from baseline to end of study, approximately 3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amber Glasses and Fixed Wake | Participants wore 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 was reached. Participants were also required to wake up at the same time (±30 mins). Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. Robert Auger, M.D. | Mayo Clinic | 507-266-1066 | Auger.Raymond1@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2021 | May 2, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Clear Lens Glasses | Device | Half of the participants will be wearing the clear glasses to see if the glasses help with sleep onset. |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| BG001 | Clear Glasses and Free Wake | Participants wore 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 was reached. Participants were given instructions regarding sleep schedule. Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Clear Glasses and Free Wake |
Participants wore 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 was reached. Participants were given instructions regarding sleep schedule. Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset. |
|
|
| Primary | 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. | Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm | Posted | Mean | Standard Deviation | hours | baseline, week 3 |
|
|
|
| Primary | 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. | Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm | Posted | Mean | Standard Deviation | decimal military time | baseline, week 3 |
|
|
|
| Primary | 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. | Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm | Posted | Mean | Standard Deviation | hours | baseline, week 2 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Clear Glasses and Free Wake | Participants wore 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 was reached. Participants were given instructions regarding sleep schedule. Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |