Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00834886
Other study ID # 00834886
Secondary ID
Status Completed
Phase Phase 4
First received January 9, 2009
Last updated March 9, 2016
Start date October 2008
Est. completion date January 2012

Study information

Verified date March 2016
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Melatonin
Capsules, 3 mg, once every night
Other:
Bright light
Bright light therapy 10.000 lux by Miljølys AS
Placebo red light
Red light 400 lux as placebo light
Placebo capsule
Capsules containing 3 mng rice flour, once every night

Locations

Country Name City State
Norway University of Bergen Bergen

Sponsors (1)

Lead Sponsor Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Saxvig IW, Wilhelmsen-Langeland A, Pallesen S, Vedaa O, Nordhus IH, Bjorvatn B. A randomized controlled trial with bright light and melatonin for delayed sleep phase disorder: effects on subjective and objective sleep. Chronobiol Int. 2014 Feb;31(1):72-86 — View Citation

Wilhelmsen-Langeland A, Saxvig IW, Pallesen S, Nordhus IH, Vedaa Ø, Lundervold AJ, Bjorvatn B. A randomized controlled trial with bright light and melatonin for the treatment of delayed sleep phase disorder: effects on subjective and objective sleepiness — View Citation

Outcome

Type Measure Description Time frame Safety issue
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.
1 day after two-week treatment ends Yes
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"). 1 day after 2-week treatment ended No
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. 1 day after 2-week treatment ended No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02962037 - Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities Before Handling the Disorder? Phase 4
Recruiting NCT04690504 - Validation of Circadian Biomarkers in Patients With Sleep Disorders
Recruiting NCT04792697 - Experimental Manipulation of Sleep and Circadian Rhythms and the Role Played on Reward Function in Teens N/A
Recruiting NCT03956745 - Biomarkers for Circadian Timing in Healthy Adults
Active, not recruiting NCT03980340 - Breath Biomarkers for Sleep Loss and Circadian Timing
Completed NCT03715465 - The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder Phase 3
Recruiting NCT05463861 - Lemborexant in Delayed Sleep Phase Syndrome Phase 4
Completed NCT01419938 - Does Cognitive Behaviour Therapy (CBT) Improve the Effect of Light Therapy N/A
Recruiting NCT00282061 - Synchronization and Desynchronization Between Circadian Rhythms in Patients With Delayed Sleep Phase Syndrome (DSPS) Phase 1