Delayed Sleep-Wake Phase Disorder
Conditions
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.
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.
Interventions
DEVICEAmber Glasses
Half of the participants will be wearing the amber glasses to see if they can help with sleep onset.
DEVICEClear Lens Glasses
Half of the participants will be wearing the clear glasses to see if the glasses help with sleep onset.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in School Night Sleep Onset Time | 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 | 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) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Amber Glasses and Fixed Wake | Total | Clear Glasses and Free Wake |
|---|---|---|---|
| Age, Continuous | 16.5 years STANDARD_DEVIATION 1.2 | 16.6 years STANDARD_DEVIATION 1.2 | 16.8 years STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 29 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 22 Participants | 13 Participants |
| Region of Enrollment United States | 17 participants | 34 participants | 17 participants |
| Sex: Female, Male Female | 14 Participants | 26 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: baseline, week 3
Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amber Glasses and Fixed Wake | Change in Dim Light Melatonin Onset (DLMO) | baseline | 21.51 decimal military time | Standard Deviation 1.55 |
| Amber Glasses and Fixed Wake | Change in Dim Light Melatonin Onset (DLMO) | week 3 | 21.11 decimal military time | Standard Deviation 1.12 |
| Clear Glasses and Free Wake | Change in Dim Light Melatonin Onset (DLMO) | baseline | 22.36 decimal military time | Standard Deviation 2.18 |
| Clear Glasses and Free Wake | Change in Dim Light Melatonin Onset (DLMO) | week 3 | 23.05 decimal military time | Standard Deviation 2.17 |
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.
Time frame: baseline, week 2
Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amber Glasses and Fixed Wake | Change in Dim Light Melatonin Onset (DLMO) Phase Shift | 1.0 hours | Standard Deviation 2 |
| Clear Glasses and Free Wake | Change in Dim Light Melatonin Onset (DLMO) Phase Shift | 0.4 hours | Standard Deviation 1.1 |
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.
Time frame: baseline, week 3
Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amber Glasses and Fixed Wake | Change in Non-school Night Sleep Onset Time | 1.1 hours | Standard Deviation 1 |
| Clear Glasses and Free Wake | Change in Non-school Night Sleep Onset Time | 0.03 hours | Standard Deviation 1 |
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.
Time frame: baseline, week 3
Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amber Glasses and Fixed Wake | Change in School Night Sleep Onset Time | 0.4 hours | Standard Deviation 1.3 |
| Clear Glasses and Free Wake | Change in School Night Sleep Onset Time | 0.6 hours | Standard Deviation 1 |