Delayed Sleep Phase SyndromePhase 4NCT00834886
Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome
A Phase 4 study testing Melatonin and Bright light in people with Delayed Sleep Phase Syndrome, run by University of Bergen at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Delayed Sleep Phase Syndrome
- What is being tested?
- Melatonin and Bright light
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2008to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-25 years old
- lives in the Bergen area
- has Delayed Sleep Phase Disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment
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.
Read the 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.
- Conditions
- Delayed Sleep Phase Syndrome
- Being tested
- Melatonin, Bright light, Placebo red light, Placebo capsule
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Also called Nature´s One melatonin, by Asman, Inc.
Capsules, 3 mg, once every night
Bright lightOther
Bright light therapy 10.000 lux by Miljølys AS
Placebo red lightOther
Red light 400 lux as placebo light
Placebo capsuleOther
Capsules containing 3 mng rice flour, once every night
| Study group | Role | What they receive |
|---|---|---|
| Combination | Active comparator | Bright light 10.000 lux + melatonin 3 mg Receives: Dietary Supplement: Melatonin; Other: Bright light |
| Melatonin | Active comparator | Melatonin 3 mg + placebo red light 400 lux Receives: Dietary Supplement: Melatonin; Other: Placebo red light |
| Bright light | Active comparator | Bright light 10.000 lux + placebo capsule 3 mg rice flour Receives: Other: Bright light; Other: Placebo capsule |
| Placebo | Placebo comparator | Placebo Red light 400 lux + placebo capsule 3 mg rice flour Receives: Other: Placebo red light; Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day after two-week treatment ends
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").
Measured: 1 day after 2-week treatment ended
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.
Measured: 1 day after 2-week treatment ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delayed Sleep Phase SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjorn Bjorvatn, University of Bergen
- Investigators
- Bjørn Bjorvatn, MD., PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834886
- Sponsor's protocol ID
- 00834886
- Status last verified
- Mar 2016
- First submitted
- 9 Jan 2009
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Publications from the stury are reported here. IPD can be retrieved upon request to the study investigator.
Publications
Wilhelmsen-Langeland A, Saxvig IW, Pallesen S, Nordhus IH, Vedaa O, 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 and cognitive function. J Biol Rhythms. 2013 Oct;28(5):306-21. doi: 10.1177/0748730413500126.
PubMed 24132057Saxvig 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. doi: 10.3109/07420528.2013.823200. Epub 2013 Oct 21.
PubMed 24144243
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment
- ClinicalTrials.gov ID
- NCT00834886
- Acronym / sponsor ID
- 00834886
- Conditions
- Delayed Sleep Phase Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 8 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combination | Active comparator | Dietary Supplement: Melatonin, Other: Bright lightBright light 10.000 lux + melatonin 3 mg |
| Melatonin | Active comparator | Dietary Supplement: Melatonin, Other: Placebo red lightMelatonin 3 mg + placebo red light 400 lux |
| Bright light | Active comparator | Other: Bright light, Other: Placebo capsuleBright light 10.000 lux + placebo capsule 3 mg rice flour |
| Placebo | Placebo comparator | Other: Placebo red light, Other: Placebo capsulePlacebo Red light 400 lux + placebo capsule 3 mg rice flour |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 16-25 years old
- lives in the Bergen area
- has Delayed Sleep Phase Disorder
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: Nature´s One melatonin, by Asman, Inc.Capsules, 3 mg, once every night | Dietary supplement | Combination, Melatonin |
| Bright lightBright light therapy 10.000 lux by Miljølys AS | Other | Bright light, Combination |
| Placebo red lightRed light 400 lux as placebo light | Other | Melatonin, Placebo |
| Placebo capsuleCapsules containing 3 mng rice flour, once every night | Other | Bright light, Placebo |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24132057Wilhelmsen-Langeland A, Saxvig IW, Pallesen S, Nordhus IH, Vedaa O, 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 and cognitive function. J Biol Rhythms. 2013 Oct;28(5):306-21. doi: 10.1177/0748730413500126.
- Results publication: PubMed 24144243Saxvig 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. doi: 10.3109/07420528.2013.823200. Epub 2013 Oct 21.
- Individual participant dataSharing planned: No. Publications from the stury are reported here. IPD can be retrieved upon request to the study investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Bjorvatn, MD., PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin and Bright light in people with Delayed Sleep Phase Syndrome, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 day after two-week treatment ends). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00834886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.