Delayed Sleep Phase SyndromeNCT01419938
Does Cognitive Behaviour Therapy (CBT) Improve the Effect of Light Therapy
A study testing Light therapy and Cognitive behaviour therapy and Light therapy in people with Delayed Sleep Phase Syndrome, run by Uppsala University at 1 site in Sweden.
Trial summary
Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian clock is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at night and sleeps until 02.00-03.00 in the afternoon. Read more about this study
- Who is it for?
- Ages 16 to 26 years
- Conditions the study is for
- Delayed Sleep Phase Syndrome
- What is being tested?
- Light therapy and Cognitive behaviour therapy and Light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of delayed sleep phase syndrome.
Who cannot join
- Eye diseases
- Active psychiatric disorder.
- Ongoing somatic disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does CBT Improve the Effect of Light Therapy in Delayed Sleep Phase Syndrome Compared to Only Light Therapy - Short and Long Term Follow up
Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian clock is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at night and sleeps until 02.00-03.00 in the afternoon. This syndrome is most frequent among young people between 16-25 years, which conveys that school attendance and education are affected, and also often results in severe social consequences. DSPS is sometimes associated with depression and personality disorders and may aggravate psychiatric symptoms.
This syndrome is highly underdiagnosed and there are no detailed guidelines how to treat it. The treatment usually consists of light therapy, chronotherapy or melatonin. There is a lack of guidelines how often, with which wavelength, and how long the treatment of DSPS patients shall go on. Previous studies shows that light therapy often is effective. The effect gets even better if melatonin is administered concurrently. However, the frequency of relapse is high.
Read more
Thus, DSPS is a prevalent syndrome in young adults with severe consequences on normal daytime functioning. There are almost no treatment options available in health care settings. There is a clear need for further studies on this topic. The main purpose of the present study is to evaluate the clinical effects of short and long-term treatment by using light therapy and cognitive behaviour therapy (CBT). CBT is recommended at mild to moderate depression and anxiety. It also has some evidence in treating insomnia. Patients with DSPS often have al of these symptoms and therefore the investigators would like to investigate if CBT can enhance the effect of light therapy.
Firstly, the investigators want to evaluate the short-term effects of light therapy with and without CBT. Secondly, the investigators want to evaluate if the patients who get CBT maintain a "normal" sleep rhythm and prevent relapse of DSPS compared to just light therapy for two weeks.
The investigators also want to evaluate how this patient-group differs when it comes to behavioral factors compared to a matched reference group.
Read the detailed description
DSPS patients delayed sleep and wake times are accompanied by insomnia and excessive sleepiness that results in functional impairments. The sleeping-problems and the impairment in important areas of functioning and quality of life sometimes lead to psychiatric problems such as, depressive symptoms, irritability, problems with their memory and concentration. It has not yet been fully established how long the treatment should go on, how long each light treatment should be, and the exact intensity of light. Although long-term studies on DSPS patients are sparse, it is known from clinical experience that these patients often fall back into their old circadian schedule after the treatment.
This study is a prospective randomised study. In the short-term study patients will be randomised to two groups. Group I light therapy (LT) for two weeks Group II LT for two weeks + CBT for four weeks. Group I and II will be followed up with questionnaires concerning depression/anxiety, sleepiness during the day, sleep-diary and insomnia-problems.
The aim is to evaluate if CBT enhance LT-treatment at home. The two groups will be followed with sleep-diary monthly and questionnaires.
Method. Questionnaires. All patients will fill in some questionnaires before the treatment starts, during treatment and at follow-up.
- Horne-Ostberg Morning-Eveningness Questionnaire (MEQ) to measure their diurnality.
II) Insomnia Severity Scale (ISI), a scale that measures the severity of insomnia III) Epworth Sleepiness Scale (ESS), a scale that measures habitual daytime sleepiness.
IV) Hospital anxiety- depression scale (HADS) V) Penn state Worry Questionnaire (PSWQ) VI)Symptom-focused Rumination Scale (SRS) VII) Brief COPE(BC) The same questionaires will be given to a matched reference group, but without sleeping problems.
Light therapy: It is today considered that the most effective light intensity is 10 000 lux at approximately one foot from the person and during 30-45 minutes. This treatment will be applied at home. The exact time schedule for the light treatment will be decided individually depending on the patient's sleep diary. Each day the time for light therapy will be brought back one hour earlier and thereby getting out of bed.
CBT will be given for 90-120 minutes by a psychologist once per week for four weeks at our Sleep Department. The therapy will be given in groups of 4-6 persons.
DLMO. DLMO will only be taken before the study starts to evaluate the shift in circadian rhythm. DLMO is the time when endogenous melatonin reaches a threshold of 3 ng/L or 4 ng/L in saliva. To measure melatonin in saliva is the most commonly used way to determine DLMO since it is both easy and safe for the patient and it gives a value that follows the melatonin blood-value, only it is three times lower. The saliva test will be taken hourly for about five hours, during a window when we suspect DLMO to appear. It is important that the saliva collection must be done under dim light conditions (less then 10 lux).
- Conditions
- Delayed Sleep Phase Syndrome
- Being tested
- Light therapy and Cognitive behaviour therapy, Light therapy
- Keywords
- Light therapy, circadian rhythm, CBT
- 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.
Light therapy and Cognitive behaviour therapyDevice
Light therapy every morning during 30 minutes for two weeks. CBT for 90 to 120 minutes weekly during four weeks.
Light therapyDevice
Light therapy every morning during 30-45 minutes for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Light therapy for two weeks | Active comparator | Not described Receives: Device: Light therapy |
| Light therapy and CBT | Active comparator | Two weeks of light therapy and after that 4 weeks of Cognitive behaviour therapy (CBT) Receives: Device: Light therapy and Cognitive behaviour therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sleep-diary at 6 months.
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier.
Measured: Change from baseline in sleep-diary at 6 months.
Secondary outcomes (16)
Changes from baseline in sleep-diary at 6 weeks.
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier.
Measured: Changes from baseline in sleep diary at 6 weeks.
Change from baseline in Hospital anxiety-depression scale at 2 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Hospital anxiety-depression scale at 2 weeks
Change from baseline in Hospital anxiety-depression scale at 6 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Hospital anxiety-depression scale at 6 weeks
Change from baseline in Hospital anxiety-depression scale at 6 months
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Hospital anxiety-depression scale at 6 months
Change from baseline in Insomnia Severity Scale at 2 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Insomnia Severity Scale at 2 weeks
Change from baseline in Insomnia Severity Scale at 6 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Insomnia Severity Scale at 6 weeks
Change from baseline in Insomnia Severity Scale at 6 months
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Insomnia Severity Scale at 6 months
Change from baseline in Epworth Sleepiness Scale at 2 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Epworth Sleepiness Scale at 2 weeks
Change from baseline in Epworth Sleepiness Scale at 6 weeks
By comparing the results of the questionnaires before study start, during and after study completion, knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Epworth Sleepiness Scale at 6 weeks
Change from baseline in Epworth Sleepiness Scale at 6 months
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Epworth Sleepiness Scale at 6 months
Change from baseline in Penn State Worry Questionnaire at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Penn State Worry Questionnaire at 6 months
Change from baseline in Symptom-focused Rumination Scale at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Symptom-focused Rumination Scale at 6 months
Change from baseline in Brief COPE at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group's coping strategies will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Brief COPE at 6 months
Change from baseline in sleep-diary at 2 weeks
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier
Measured: Change from baseline in sleep-diary at 2 weeks
Number of participants that will keep their new sleep-timings.
We want to measure how many participants that can keep their new sleep-timings after the first treatment (6 weeks). We believe that CBT or light-therapy intermittently can help these patients to avoid relapses
Measured: 6 months
Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Measured: Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Responsible party
- Principal investigator, Katarina Danielsson, Uppsala University
- Investigators
- Katarina ML Danielsson, M.D., Principal investigator, Sleep department, Uppsala University Hospital, SwedenAgneta Markstroem, Ass. Prof., Principal investigator, Sleep department, Uppsala University Hospital, SwedenJan-Erik Broman, Ass. Prof., Principal investigator, Sleep department, Uppsala University Hospital, SwedenMarkus Jansson-Fröjmark, Ass. Prof., Principal investigator, Department of Psychology, Stockholm University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419938
- Sponsor's protocol ID
- 2011/167
- Status last verified
- Apr 2013
- First submitted
- 26 Jul 2011
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Benloucif S, Burgess HJ, Klerman EB, Lewy AJ, Middleton B, Murphy PJ, Parry BL, Revell VL. Measuring melatonin in humans. J Clin Sleep Med. 2008 Feb 15;4(1):66-9.
PubMed 18350967Gooley JJ. Treatment of circadian rhythm sleep disorders with light. Ann Acad Med Singap. 2008 Aug;37(8):669-76.
PubMed 18797560Bjorvatn B, Pallesen S. A practical approach to circadian rhythm sleep disorders. Sleep Med Rev. 2009 Feb;13(1):47-60. doi: 10.1016/j.smrv.2008.04.009. Epub 2008 Oct 8.
PubMed 18845459Dagan Y, Yovel I, Hallis D, Eisenstein M, Raichik I. Evaluating the role of melatonin in the long-term treatment of delayed sleep phase syndrome (DSPS). Chronobiol Int. 1998 Mar;15(2):181-90. doi: 10.3109/07420529808998682.
PubMed 9562922
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does CBT Improve the Effect of Light Therapy in Delayed Sleep Phase Syndrome Compared to Only Light Therapy - Short and Long Term Follow up
- ClinicalTrials.gov ID
- NCT01419938
- Acronym / sponsor ID
- 2011/167
- Conditions
- Delayed Sleep Phase Syndrome
- Keywords
- Light therapy, circadian rhythm, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Study start
- Aug 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian clock is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at night and sleeps until 02.00-03.00 in the afternoon. This syndrome is most frequent among young people between 16-25 years, which conveys that school attendance and education are affected, and also often results in severe social consequences. DSPS is sometimes associated with depression and personality disorders and may aggravate psychiatric symptoms.
This syndrome is highly underdiagnosed and there are no detailed guidelines how to treat it. The treatment usually consists of light therapy, chronotherapy or melatonin. There is a lack of guidelines how often, with which wavelength, and how long the treatment of DSPS patients shall go on. Previous studies shows that light therapy often is effective. The effect gets even better if melatonin is administered concurrently. However, the frequency of relapse is high.
Thus, DSPS is a prevalent syndrome in young adults with severe consequences on normal daytime functioning. There are almost no treatment options available in health care settings. There is a clear need for further studies on this topic. The main purpose of the present study is to evaluate the clinical effects of short and long-term treatment by using light therapy and cognitive behaviour therapy (CBT). CBT is recommended at mild to moderate depression and anxiety. It also has some evidence in treating insomnia. Patients with DSPS often have al of these symptoms and therefore the investigators would like to investigate if CBT can enhance the effect of light therapy.
Firstly, the investigators want to evaluate the short-term effects of light therapy with and without CBT. Secondly, the investigators want to evaluate if the patients who get CBT maintain a "normal" sleep rhythm and prevent relapse of DSPS compared to just light therapy for two weeks.
The investigators also want to evaluate how this patient-group differs when it comes to behavioral factors compared to a matched reference group.
Detailed description
DSPS patients delayed sleep and wake times are accompanied by insomnia and excessive sleepiness that results in functional impairments. The sleeping-problems and the impairment in important areas of functioning and quality of life sometimes lead to psychiatric problems such as, depressive symptoms, irritability, problems with their memory and concentration. It has not yet been fully established how long the treatment should go on, how long each light treatment should be, and the exact intensity of light. Although long-term studies on DSPS patients are sparse, it is known from clinical experience that these patients often fall back into their old circadian schedule after the treatment.
This study is a prospective randomised study. In the short-term study patients will be randomised to two groups. Group I light therapy (LT) for two weeks Group II LT for two weeks + CBT for four weeks. Group I and II will be followed up with questionnaires concerning depression/anxiety, sleepiness during the day, sleep-diary and insomnia-problems.
The aim is to evaluate if CBT enhance LT-treatment at home. The two groups will be followed with sleep-diary monthly and questionnaires.
Method. Questionnaires. All patients will fill in some questionnaires before the treatment starts, during treatment and at follow-up.
- Horne-Ostberg Morning-Eveningness Questionnaire (MEQ) to measure their diurnality.
II) Insomnia Severity Scale (ISI), a scale that measures the severity of insomnia III) Epworth Sleepiness Scale (ESS), a scale that measures habitual daytime sleepiness.
IV) Hospital anxiety- depression scale (HADS) V) Penn state Worry Questionnaire (PSWQ) VI)Symptom-focused Rumination Scale (SRS) VII) Brief COPE(BC) The same questionaires will be given to a matched reference group, but without sleeping problems.
Light therapy: It is today considered that the most effective light intensity is 10 000 lux at approximately one foot from the person and during 30-45 minutes. This treatment will be applied at home. The exact time schedule for the light treatment will be decided individually depending on the patient's sleep diary. Each day the time for light therapy will be brought back one hour earlier and thereby getting out of bed.
CBT will be given for 90-120 minutes by a psychologist once per week for four weeks at our Sleep Department. The therapy will be given in groups of 4-6 persons.
DLMO. DLMO will only be taken before the study starts to evaluate the shift in circadian rhythm. DLMO is the time when endogenous melatonin reaches a threshold of 3 ng/L or 4 ng/L in saliva. To measure melatonin in saliva is the most commonly used way to determine DLMO since it is both easy and safe for the patient and it gives a value that follows the melatonin blood-value, only it is three times lower. The saliva test will be taken hourly for about five hours, during a window when we suspect DLMO to appear. It is important that the saliva collection must be done under dim light conditions (less then 10 lux).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light therapy for two weeks | Active comparator | Device: Light therapy |
| Light therapy and CBT | Active comparator | Device: Light therapy and Cognitive behaviour therapyTwo weeks of light therapy and after that 4 weeks of Cognitive behaviour therapy (CBT) |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of delayed sleep phase syndrome.
Key exclusion criteria (3 listed)
- Eye diseases
- Active psychiatric disorder.
- Ongoing somatic disorder.
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 |
|---|---|---|
| Light therapy and Cognitive behaviour therapyLight therapy every morning during 30 minutes for two weeks. CBT for 90 to 120 minutes weekly during four weeks. | Device | Light therapy and CBT |
| Light therapyLight therapy every morning during 30-45 minutes for two weeks. | Device | Light therapy for two weeks |
Primary outcome
Change from baseline in sleep-diary at 6 months.
Time frame: Change from baseline in sleep-diary at 6 months.
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier.
16 secondary outcomes
Changes from baseline in sleep-diary at 6 weeks.
Time frame: Changes from baseline in sleep diary at 6 weeks.
Change from baseline in Hospital anxiety-depression scale at 2 weeks
Time frame: Change from baseline in Hospital anxiety-depression scale at 2 weeks
Change from baseline in Hospital anxiety-depression scale at 6 weeks
Time frame: Change from baseline in Hospital anxiety-depression scale at 6 weeks
Change from baseline in Hospital anxiety-depression scale at 6 months
Time frame: Change from baseline in Hospital anxiety-depression scale at 6 months
Change from baseline in Insomnia Severity Scale at 2 weeks
Time frame: Change from baseline in Insomnia Severity Scale at 2 weeks
Change from baseline in Insomnia Severity Scale at 6 weeks
Time frame: Change from baseline in Insomnia Severity Scale at 6 weeks
Change from baseline in Insomnia Severity Scale at 6 months
Time frame: Change from baseline in Insomnia Severity Scale at 6 months
Change from baseline in Epworth Sleepiness Scale at 2 weeks
Time frame: Change from baseline in Epworth Sleepiness Scale at 2 weeks
Change from baseline in Epworth Sleepiness Scale at 6 weeks
Time frame: Change from baseline in Epworth Sleepiness Scale at 6 weeks
Change from baseline in Epworth Sleepiness Scale at 6 months
Time frame: Change from baseline in Epworth Sleepiness Scale at 6 months
Change from baseline in Penn State Worry Questionnaire at 6 months
Time frame: Change from baseline in Penn State Worry Questionnaire at 6 months
Change from baseline in Symptom-focused Rumination Scale at 6 months
Time frame: Change from baseline in Symptom-focused Rumination Scale at 6 months
Change from baseline in Brief COPE at 6 months
Time frame: Change from baseline in Brief COPE at 6 months
Change from baseline in sleep-diary at 2 weeks
Time frame: Change from baseline in sleep-diary at 2 weeks
Number of participants that will keep their new sleep-timings.
Time frame: 6 months
Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months
Time frame: Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Background: PubMed 18350967Benloucif S, Burgess HJ, Klerman EB, Lewy AJ, Middleton B, Murphy PJ, Parry BL, Revell VL. Measuring melatonin in humans. J Clin Sleep Med. 2008 Feb 15;4(1):66-9.
- Background: PubMed 18797560Gooley JJ. Treatment of circadian rhythm sleep disorders with light. Ann Acad Med Singap. 2008 Aug;37(8):669-76.
- Background: PubMed 18845459Bjorvatn B, Pallesen S. A practical approach to circadian rhythm sleep disorders. Sleep Med Rev. 2009 Feb;13(1):47-60. doi: 10.1016/j.smrv.2008.04.009. Epub 2008 Oct 8.
- Background: PubMed 9562922Dagan Y, Yovel I, Hallis D, Eisenstein M, Raichik I. Evaluating the role of melatonin in the long-term treatment of delayed sleep phase syndrome (DSPS). Chronobiol Int. 1998 Mar;15(2):181-90. doi: 10.3109/07420529808998682.
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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.
Katarina ML Danielsson, M.D. principal investigator
Sleep department, Uppsala University Hospital, Sweden
Agneta Markstroem, Ass. Prof. principal investigator
Sleep department, Uppsala University Hospital, Sweden
Jan-Erik Broman, Ass. Prof. principal investigator
Sleep department, Uppsala University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy and Cognitive behaviour therapy and Light therapy in people with Delayed Sleep Phase Syndrome, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 3 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 25 Apr 2013. 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 Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in sleep-diary at 6 months. (time frame: Change from baseline in sleep-diary at 6 months.). 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 NCT01419938, which also lists 4 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 25 Apr 2013; AzTrials last refreshed its copy on 30 Oct 2026.