Trial Outcomes & Findings for Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome (NCT NCT00834886)
NCT ID: NCT00834886
Last Updated: 2016-03-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
1 day after two-week treatment ends
Results posted on
2016-03-14
Participant Flow
Participant milestones
| Measure |
Combination
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Melatonin
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light
|
Bright Light
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Placebo
Placebo melatonin + placebo light therapy
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome
Baseline characteristics by cohort
| Measure |
Melatonin and Light Therapy
n=10 Participants
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Melatonin and Placebo Light
n=10 Participants
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light
|
Placebo Melatonin and Light Therapy
n=10 Participants
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Placebo Melatonin and Placebo Light
n=10 Participants
Placebo melatonin + placebo light therapy
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
20.3 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
21.2 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
20.7 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
20.8 years
STANDARD_DEVIATION 3.4 • n=4 Participants
|
20.7 years
STANDARD_DEVIATION 3.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
Norway
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 day after two-week treatment endsSleep 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.
Outcome measures
| Measure |
Combination
n=10 Participants
Bright light + melatonin
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Melatonin
n=10 Participants
Melatonin + placebo light
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light
|
Bright Light
n=10 Participants
Bright light + placebo capsule
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Placebo
n=10 Participants
Placebo capsule + placebo light
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo 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.
|
530 Minutes
Standard Deviation 121
|
506 Minutes
Standard Deviation 98
|
520 Minutes
Standard Deviation 148
|
543 Minutes
Standard Deviation 163
|
PRIMARY outcome
Timeframe: 1 day after 2-week treatment endedPopulation: All participants in the four arms
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").
Outcome measures
| Measure |
Combination
n=10 Participants
Bright light + melatonin
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Melatonin
n=10 Participants
Melatonin + placebo light
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light
|
Bright Light
n=10 Participants
Bright light + placebo capsule
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Placebo
n=10 Participants
Placebo capsule + placebo light
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo 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.
|
6.0 units on a scale
Standard Deviation 1.6
|
5.9 units on a scale
Standard Deviation 1.3
|
6.3 units on a scale
Standard Deviation 1.8
|
6.5 units on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 1 day after 2-week treatment endedActigraphy, 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.
Outcome measures
| Measure |
Combination
n=10 Participants
Bright light + melatonin
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Melatonin
n=10 Participants
Melatonin + placebo light
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light
|
Bright Light
n=10 Participants
Bright light + placebo capsule
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Placebo
n=10 Participants
Placebo capsule + placebo light
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo 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.
|
11 Minutes
Standard Deviation 8
|
21 Minutes
Standard Deviation 19
|
15 Minutes
Standard Deviation 10
|
24 Minutes
Standard Deviation 11
|
Adverse Events
Combination
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Melatonin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Bright Light
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combination
n=10 participants at risk
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Melatonin
n=10 participants at risk
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light
|
Bright Light
n=10 participants at risk
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS
|
Placebo
n=10 participants at risk
Placebo melatonin + placebo light therapy
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
2/10
|
10.0%
1/10
|
10.0%
1/10
|
20.0%
2/10
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
20.0%
2/10
|
0.00%
0/10
|
0.00%
0/10
|
|
Eye disorders
Discomfort in eyes
|
20.0%
2/10
|
10.0%
1/10
|
10.0%
1/10
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place