Delayed Sleep-Wake Phase DisorderSIPNCT05177055
Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)
A study testing Group-based light therapy at gradually advanced timing for DSWPD, Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses and 6-week wait list for sleep-school in people with Delayed Sleep-Wake Phase Disorder and Sleep Disorder, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delayed Sleep-Wake Phase Disorder, Sleep Disorder, Psychiatric Disorder
- What is being tested?
- Group-based light therapy at gradually advanced timing for DSWPD, Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses and 6-week wait list for sleep-school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNorway
- Study dates
- 23 May 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital
- Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for DSWPD comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to DSWPD and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
Who cannot join
- Night work
- Patients that do not fulfil the DSM-V criteria for DSWPD comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Tertnes, 5113
Ane Wilhelmsen-Langeland, PhD, +47 92843253, ane.wilhelmsen-langeland@helse-bergen.no
Veronika A Vågenes, BA, +47 90078867, veronika.alice.vågenes@helse-bergen.no
- Recruiting
Haukeland University Hospital
Bergen, 5113
Ane Wilhelmsen-Langeland, PhD, +47 92843253, ane.wilhelmsen-langeland@helse-bergen.no
Berge Osnes, PhD, +47 92445081, berge.osnes@uib.no
About this study
Official title: Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The recommended treatment for Delayed Sleep-Wake phase disorder is light therapy at gradually advanced timing and/or melatonin administered in order to help phase-advance the circadian rhythm. There is a great gap in the knowledge on how sleep disorders can be treated effectively when they occur comorbid to moderate and severe psychiatric illness. In this project the we therefore seek to investigate the effect of psychological and behavioural, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures.
Read the detailed description
The recommended treatment for Delayed Sleep-Wake phase disorder is bright light therapy (LT) at gradually advanced timing and/or melatonin administered in order to phase-advance the circadian rhythm. Recent research has proven that dark therapy, or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an advancing effect on the circadian rhythm. The investigators therefore also want to test bb-glasses as an additive treatment to LT at gradually advanced timing.
The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The DSWPD-group gets together every other Monday from 1 pm until 3 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their treatment, this often leads the group to function as a support for each other. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS in Bergen, Norway. Participants have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT, hence the project has high ecological validity.
All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, sleep-diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based LT at gradually advanced timing. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 6 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are on a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist, hence both groups are in active treatment for their symptoms. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based LT at gradually advanced timing for 6 weeks or b) group-based group-based LT at gradually advanced timing for 6 weeks and bb-glasses. All participant will be followed up after 12 months.
- Being tested
- Group-based light therapy at gradually advanced timing for DSWPD, Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses, 6-week wait list for sleep-school
- Keywords
- Sleep disorders, Delayed sleep-wake phase disorder, blue-blocking glasses, psychiatric disorders, group-based treatment for circadian rhythm sleep disorder
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Sleep Wake Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based light therapy at gradually advanced timing for DSWPDBehavioural
Also called Group-LT at gradually advanced timing
Light therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques
Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glassesBehavioural
Also called Group-LT at gradually advanced timing & bb-glasses
Light therapy (LT) at gradually advanced timing, bb-glasses 12 hrs after LT, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques
6-week wait list for sleep-schoolOther
Also called Treatment as usual (TAU)
Treatment as usual in a psychiatric outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| n=15, sleep-school 6 weeks | Experimental | Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep-school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. Receives: Behavioral: Group-based light therapy at gradually advanced timing for DSWPD |
| n=15, sleep-school 6 weeks and additive bb-glasses | Experimental | Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. Receives: Behavioral: Group-based light therapy at gradually advanced timing for DSWPD; Behavioral: Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses |
| n=30 Six-week wait list for sleep-school | Active comparator | Patients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. Receives: Other: 6-week wait list for sleep-school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes (advancement) of sleep timing
Measured by sleep diaries, Genactiv actigraphy and saliva samples (intraindividual variation of rise time (IIV), dim light melatonin onset (DLMO), rise /wake up time)
Measured: baseline, post intervention after 6 weeks, follow-up after 12 months
Secondary outcomes (24)
Changes in objective sleep onset latency (SOL)
Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of minutes of average sleep onset latency.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Sleep efficiency (SE)
Measured by sleep diary; total sleep time/time in bed x 100= percentage SE
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in Time in bed (TIB)
Measured by sleep diary; time from bed-time to rise time
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in immediate sleepiness
Measured by the Karolinska Sleepiness Scale (KSS). The KSS measure subjective sleepiness at a specific time point (noon). The scale gives a number from 1-9 where 9 indicates "trouble staying awake" and is the worst outcome.
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective total sleep length/time asleep (TST)
Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average total sleep time.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Work status
Status of employment/unemployment, percentage disability benefits received
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Total sleep length/time asleep (TST)
Measured by sleep diary; time in minutes from bed-time to estimated sleep onset
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in Early morning awakening (EMA)
Measured by sleep diary; minutes awake before rise time
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective sleep efficiency (SE)
Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number from 0-100% that gives average sleep efficiency.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in objective early morning awakening (EMA)
Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes early morning awakening.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in well-being
Measured by the World Health Organisation Five Well-Being Index (WHO-5)
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in sleepiness
Measured by the Epworth Sleepiness Scale (ESS). The ESS is an 8-item scale where the respondent grades the likelihood of falling asleep or dozing off in different daily situations. The responses are graded on a 4-point likert scale 0=no likelihood to 3=very likely. A score of 11 or higher is considered an indication of excessive daytime sleepiness.
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective wake after sleep onset (WASO)
Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes awake after sleep onset.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in beliefs about sleep
Measured by Dysfunctional Beliefs About Sleep (DBAS-16). The DBAS-16 measures the degree of dysfunctional beliefs about sleep with 16 items. It has 4 subscales (1) sleep-related worry and helplessness; 2) beliefs about sleep medications; 3) expectations about sleep need; and 4) beliefs about the consequences/effects of insomnia and 1 total scale score. The higher the score, the more dysfunctional beliefs about sleep.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Sleep onset latency (SOL)
Measured by sleep diary; time in minutes from bed-time to estimated sleep onset
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective time in bed (TIB)
Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average time in bed.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in fatigue
Measured by the Chalders Fatigue Scale (CFS)
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Sleep quality (SQ)
Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in Wake after sleep onset (WASO)
Measured by sleep diary; minutes awake before rise time
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in anxiety symptoms
Measured by The Beck Anxiety Inventory (BAI). The BAI measure subjective symptoms of anxiety on a scale ranging from 0-63. The higher the score, the worse the anxiety.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in depression symptoms
Measured by The Beck Depression Inventory-2 (BDI-II). The BDI measure subjective symptoms of depression on a scale ranging from 0-63. The higher the score, the worse depression.
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Daytime function (DF)
Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Suicide attempts and admittances in psychiatric wards
Whether or not suicide has been attempted, if applicable number og attempts and whether or nor the patient has been admitted to a psychitaric ward (voluntary/forced)
Measured: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in anxiety and depression
Measured by the Hospital anxiety and depression scale (HADS), Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI)
Measured: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start23 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Sleep-Wake Phase DisorderStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Ane Wilhelmsen-Langeland, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177055
- Sponsor's protocol ID
- 66304-2
- Acronym
- SIP
- Status last verified
- Jun 2024
- First submitted
- 15 Dec 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share the following individual participant data (IPD); Study protocol and Informed Consent Form (ICF)
Publications
Wilhelmsen-Langeland A, Osnes B, Gradisar M, Vagenes VA, Sorensen L, Bjorvatn B, Fasmer OB, Koenig J, Pallesen S, Saxvig IW. Group bright light therapy compared to treatment as usual for delayed sleep-wake phase disorder among patients in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial. BMJ Open. 2025 Apr 17;15(4):e093091. doi: 10.1136/bmjopen-2024-093091.
PubMed 40250869
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)
- ClinicalTrials.gov ID
- NCT05177055
- Acronym / sponsor ID
- SIP / 66304-2
- Keywords
- Sleep disorders, Delayed sleep-wake phase disorder, blue-blocking glasses, psychiatric disorders, group-based treatment for circadian rhythm sleep disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 23 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jan 2022 (actual)
- 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.
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The recommended treatment for Delayed Sleep-Wake phase disorder is light therapy at gradually advanced timing and/or melatonin administered in order to help phase-advance the circadian rhythm. There is a great gap in the knowledge on how sleep disorders can be treated effectively when they occur comorbid to moderate and severe psychiatric illness. In this project the we therefore seek to investigate the effect of psychological and behavioural, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures.
Detailed description
The recommended treatment for Delayed Sleep-Wake phase disorder is bright light therapy (LT) at gradually advanced timing and/or melatonin administered in order to phase-advance the circadian rhythm. Recent research has proven that dark therapy, or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an advancing effect on the circadian rhythm. The investigators therefore also want to test bb-glasses as an additive treatment to LT at gradually advanced timing.
The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The DSWPD-group gets together every other Monday from 1 pm until 3 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their treatment, this often leads the group to function as a support for each other. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS in Bergen, Norway. Participants have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT, hence the project has high ecological validity.
All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, sleep-diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based LT at gradually advanced timing. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 6 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are on a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist, hence both groups are in active treatment for their symptoms. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based LT at gradually advanced timing for 6 weeks or b) group-based group-based LT at gradually advanced timing for 6 weeks and bb-glasses. All participant will be followed up after 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| n=15, sleep-school 6 weeks | Experimental | Behavioral: Group-based light therapy at gradually advanced timing for DSWPDPatients receive treatment as usual in the psychiatric clinic combined with participation in the sleep-school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. |
| n=15, sleep-school 6 weeks and additive bb-glasses | Experimental | Behavioral: Group-based light therapy at gradually advanced timing for DSWPD, Behavioral: Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glassesPatients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. |
| n=30 Six-week wait list for sleep-school | Active comparator | Other: 6-week wait list for sleep-schoolPatients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital
- Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for DSWPD comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to DSWPD and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
Key exclusion criteria (2 listed)
- Night work
- Patients that do not fulfil the DSM-V criteria for DSWPD comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
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 |
|---|---|---|
| Group-based light therapy at gradually advanced timing for DSWPDAlso: Group-LT at gradually advanced timingLight therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques | Behavioural | n=15, sleep-school 6 weeks, n=15, sleep-school 6 weeks and additive bb-glasses |
| Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glassesAlso: Group-LT at gradually advanced timing & bb-glassesLight therapy (LT) at gradually advanced timing, bb-glasses 12 hrs after LT, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques | Behavioural | n=15, sleep-school 6 weeks and additive bb-glasses |
| 6-week wait list for sleep-schoolAlso: Treatment as usual (TAU)Treatment as usual in a psychiatric outpatient clinic | Other | n=30 Six-week wait list for sleep-school |
Primary outcome
Changes (advancement) of sleep timing
Time frame: baseline, post intervention after 6 weeks, follow-up after 12 months
Measured by sleep diaries, Genactiv actigraphy and saliva samples (intraindividual variation of rise time (IIV), dim light melatonin onset (DLMO), rise /wake up time)
24 secondary outcomes
Changes in objective sleep onset latency (SOL)
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Sleep efficiency (SE)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in Time in bed (TIB)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in immediate sleepiness
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective total sleep length/time asleep (TST)
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Work status
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Total sleep length/time asleep (TST)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in Early morning awakening (EMA)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective sleep efficiency (SE)
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in objective early morning awakening (EMA)
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in well-being
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in sleepiness
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective wake after sleep onset (WASO)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in beliefs about sleep
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Sleep onset latency (SOL)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in objective time in bed (TIB)
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in fatigue
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Sleep quality (SQ)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in Wake after sleep onset (WASO)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Changes in anxiety symptoms
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in depression symptoms
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in Daytime function (DF)
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Suicide attempts and admittances in psychiatric wards
Time frame: baseline and post intervention after 6 weeks, follow-up after 12 months
Changes in anxiety and depression
Time frame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 40250869Wilhelmsen-Langeland A, Osnes B, Gradisar M, Vagenes VA, Sorensen L, Bjorvatn B, Fasmer OB, Koenig J, Pallesen S, Saxvig IW. Group bright light therapy compared to treatment as usual for delayed sleep-wake phase disorder among patients in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial. BMJ Open. 2025 Apr 17;15(4):e093091. doi: 10.1136/bmjopen-2024-093091.
- Individual participant dataSharing planned: Yes. The investigators plan to share the following individual participant data (IPD); Study protocol and Informed Consent Form (ICF)
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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.
Ane Wilhelmsen-Langeland, PhD principal investigator
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based light therapy at gradually advanced timing for DSWPD, Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses and 6-week wait list for sleep-school in people with Delayed Sleep-Wake Phase Disorder and Sleep Disorder, run by Haukeland University Hospital at 2 sites 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ane Wilhelmsen-Langeland, PhD (+47 55957000 ext. 7192, ane.wilhelmsen-langeland@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes (advancement) of sleep timing (time frame: baseline, post intervention after 6 weeks, follow-up after 12 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 NCT05177055, which also lists 1 linked publication.
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 11 Jun 2024.