Delayed Sleep Phase Syndrome
Conditions
Brief summary
In this study the investigators will examine the effects of melatonin and light therapy on delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be randomized into four different groups; melatonin + light therapy (N=15), melatonin + placebo light (N=15), placebo + light therapy (N=15) and placebo + placebo light. This is a double-blinded treatment and the participants will receive this treatment for 2 weeks. Then they will be re-randomized into two groups; full treatment with light therapy + melatonin (N=30) and no treatment (N=30) for 3 months unblinded. The investigators will test the subjects pre-treatment, post 2 week treatment and after 3 months.
Detailed description
Delayed sleep phase syndrome (DSPS) is a circadian rhythm sleep disorder where the sleep-wake rhythm is significantly delayed according to the environmental demands. Hence, the symptoms consist of major difficulties falling asleep and problems awakening in due time and patients often experience work- and school related impairments (The International Classification of Sleep Disorders: Diagnostic and Coding manual, 2005). However, correct diagnosis is often not made and the treatment offered is, accordingly, often inadequate. DSPS normally develops in interplay between dysfunctional habits/behaviour and biological vulnerability. Bright light therapy and administration of exogenous melatonin comprise the most common interventions. Timed bright light has been shown to effectively phase advance the rhythm (Rosenthal et al., 1990), but no standardized guidelines regarding the duration, intensity or timing of light exposure have been established. Compliance to the treatment is often poor because it involves structuring the daily schedule, which may be hard for the relevant age group. Similarly, administration of melatonin in the evening has been shown to phase advance the rhythm (Lewy et al., 1998; Mundey, Benloucif, Harsanyi, Dubocovich, & Zee, 2005), but a standardized approach for dose, duration and timing is lacking. It is important to establish effective treatment guidelines for delayed sleep phase syndrome. Large scale studies on the effects of melatonin and bright light treatment in randomized placebo-controlled designs are needed. In a clinical trial we aim to investigate the efficacy of bright light and melatonin treatment using a 4 armed randomized placebo controlled design.
Interventions
DIETARY_SUPPLEMENTMelatonin
Capsules, 3 mg, once every night
OTHERBright light
Bright light therapy 10.000 lux by Miljølys AS
OTHERPlacebo red light
Red light 400 lux as placebo light
OTHERPlacebo capsule
Capsules containing 3 mng rice flour, once every night
Sponsors
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 16-25 years old * lives in the Bergen area * has Delayed Sleep Phase Disorder
Exclusion criteria
* pregnant or nursing women * other sleep disorders (i.e. sleep apnoea or PLMS) * moderate to serious psychiatric disease * use of psychopharmacological medicines * in psychotherapeutic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 1 day after two-week treatment ends | Sleep diary, rise time (when participants rise from bed in the morning, self-report) before and after a randomized controlled 4 armed treatment study including a follow-up 3 months later. Midnight is 0000; in the outcome measure table the value is given in minutes after midnight. i.e. 530 equals 08:50 in the morning. |
| To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 1 day after 2-week treatment ended | Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 (very alert) to 9 (very sleepy, fighting sleep, effort to stay awake). |
| To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 1 day after 2-week treatment ended | Actigraphy, sleep onset latency (SOL). An actigraph is a wrist-worn movement sensor that objectively record motor activity. Participants used an event button to mark bed time and rise time. The actiwatch is waterproof and participants were instructed not to take it off at any time during the data collection peroid. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Melatonin and Light Therapy Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS | 10 |
| Melatonin and Placebo Light Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light | 10 |
| Placebo Melatonin and Light Therapy Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS | 10 |
| Placebo Melatonin and Placebo Light Placebo melatonin + placebo light therapy
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Melatonin and Light Therapy | Melatonin and Placebo Light | Placebo Melatonin and Light Therapy | Placebo Melatonin and Placebo Light | Total |
|---|---|---|---|---|---|
| Age, Customized Age | 20.3 years STANDARD_DEVIATION 3.3 | 21.2 years STANDARD_DEVIATION 2.7 | 20.7 years STANDARD_DEVIATION 3.4 | 20.8 years STANDARD_DEVIATION 3.4 | 20.7 years STANDARD_DEVIATION 3.1 |
| Region of Enrollment Norway | 10 participants | 10 participants | 10 participants | 10 participants | 40 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 8 Participants | 7 Participants | 28 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 2 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 10 | 4 / 10 | 3 / 10 | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.
Sleep diary, rise time (when participants rise from bed in the morning, self-report) before and after a randomized controlled 4 armed treatment study including a follow-up 3 months later. Midnight is 0000; in the outcome measure table the value is given in minutes after midnight. i.e. 530 equals 08:50 in the morning.
Time frame: 1 day after two-week treatment ends
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination | To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 530 Minutes | Standard Deviation 121 |
| Melatonin | To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 506 Minutes | Standard Deviation 98 |
| Bright Light | To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 520 Minutes | Standard Deviation 148 |
| Placebo | To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 543 Minutes | Standard Deviation 163 |
Primary
To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.
Actigraphy, sleep onset latency (SOL). An actigraph is a wrist-worn movement sensor that objectively record motor activity. Participants used an event button to mark bed time and rise time. The actiwatch is waterproof and participants were instructed not to take it off at any time during the data collection peroid.
Time frame: 1 day after 2-week treatment ended
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination | To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 11 Minutes | Standard Deviation 8 |
| Melatonin | To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 21 Minutes | Standard Deviation 19 |
| Bright Light | To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 15 Minutes | Standard Deviation 10 |
| Placebo | To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 24 Minutes | Standard Deviation 11 |
Primary
To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.
Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 (very alert) to 9 (very sleepy, fighting sleep, effort to stay awake).
Time frame: 1 day after 2-week treatment ended
Population: All participants in the four arms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination | To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 6.0 units on a scale | Standard Deviation 1.6 |
| Melatonin | To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 5.9 units on a scale | Standard Deviation 1.3 |
| Bright Light | To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 6.3 units on a scale | Standard Deviation 1.8 |
| Placebo | To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. | 6.5 units on a scale | Standard Deviation 1.5 |