Shift-work DisorderSHIFTPLANNCT05452096
SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health.
A study testing Education program and ergonomic schedulling in people with Shift-work Disorder and Insomnia, run by University Hospital, Antwerp.
Trial summary
Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shift-work Disorder, Insomnia, Fatigue
- What is being tested?
- Education program and ergonomic schedulling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Professional drivers having worked in shifts with the transport company in full-time or ≥80% part-time employment in the company's regular backward-rotating schedule for at least two years.
Who cannot join
- Regular medication for high blood pressure and uncontrolled high blood pressure (defined as exceeding 140/90 mmHg) at screening, regular medication for diabetes, sleeping pills or sedative medication for depression (defined as trazodone, mirtazapine and amitriptyline). Because our secondary outcomes imply the evolution of blood-pressure and blood-sugar parameters, drivers with such pre-existing controlled or non-controlled comorbidity will not be eligible for participation.
- High risk of moderate-to-severe obstructive sleep apnea syndrome (OSAS) as assessed with the STOP-Bang questionnaire, a simple, easy to remember and self-reportable screening tool. We will use a cut-off score of 6 or higher to indicate the presence of OSAS.
- Drivers combining their job as a professional driver with another job elsewhere.
- Excessive sleepiness as defined as a score in excess of 12 on the Epworth Sleepiness Scale (ESS). Although the habitual cut-off is >9, we opted for this higher threshold because we will be examining the effect of the intervention on daytime sleepiness. All applicants with an ESS >12 will be excluded and referred to a general practitioner for further evaluation.
- A BMI higher than 35. We chose this cut-off value based on the data provided by the external occupational health service, which showed that in 2018, 42.6 % of their drivers had a mean BMI of 25-30 and 27.5 % a BMI between 30-40.
- The presence of major depression as defined by a score exceeding the threshold of 1.75 on the Hopkins Symptom Checklist (HSCL-25), where higher scores were demonstrated to be highly indicative of depressive disorder according to the DSM-5 and characterized as "a case requiring treatment".
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial Investigating the Effects of a Multimodal Shift-work Intervention on Drivers' Fatigue, Sleep, Health and Performance Parameters.
Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Epidemiological data show that shift workers are at increased risk of sleepiness, fatigue and insomnia, cardiovascular disease, breast cancer and shift-work disorder. Prevalence estimates of shift-work disorder vary between 5% and 26,5%.
Given these widespread and serious health and functional consequences of shift work, there is a necessity for treatments that improve shift workers' health and work performance. Most non-pharmacological recommendations mention improved scheduling, bright-light exposure, napping, psychoeducation fostering sleep hygiene, and cognitive-behavioral interventions.
Read more
The effects of shift work on the health, fatigue and sleepiness of drivers have been robustly investigated in observational studies, as well as the effects of single measures such as scheduling or resting times. But studies on the effectiveness of countermeasures against the adverse impact of shift work are sparse, especially for high-risk populations such as professional drivers and controlled intervention studies are lacking. Several other investigators expounded the need for a multi-level approach to managing occupational sleep-related fatigue and workplace interventions to promote sleep and health of shift workers. Highlighting the high public-health burden associated with lack of recuperative sleep, the authors pointed out the pressing need to develop policies and implement programs aimed at improving workers' sleep health.
With SHIFTPLAN, the investigators aim to fill this gap in comprehensive approaches. To their knowledge, this is the first randomised controlled trial to systematically gauge the effect of a multimodal program that includes ergonomic shift scheduling and an educational program on well-defined health, sleep and performance outcomes in professional drivers.
Read the detailed description
The duration of the intervention will be six months. The intervention provided to the intervention group is based on evidence-based good standard of care and includes: 1) Healthy scheduling (fast forward-rotating shift schedules adapted to chronotype, adequate resting times, napping, bright-light therapy); 2) Education program for drivers (psychoeducation promoting sleep hygiene, cognitive-behavioral strategies, stress-management techniques, information on chronotherapy such as bright-light therapy and napping) The control group or "waiting-list group" will include drivers who will continue working according to the default shift schedules while being assigned to a waiting list in anticipation of the education program to which they will able to suscribe after completing the study.
- Conditions
- Shift-work Disorder, Insomnia, Fatigue, Mental Health Issue, Quality of Life, Coping Skills
- Being tested
- Education program and ergonomic schedulling
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education program and ergonomic schedullingBehavioural
The duration: six months. The explicit choice for a multimodal intervention to be tested as a whole is in line with the assertion of other experts that workplace interventions using a single approach will not be effective.
Multimodal intervention
- Implementing healthy scheduling. This will imply fast forward-rotating shift schedules, being adapted to chronotype, allowing for adequate resting times between shifts and series of shifts, allowing for napping at work, in particular during the first two days of an early shift.
- Education program for drivers: psychoeducation on the sleep-wake cycle chronotypes, based on the cognitive-behavioral treatment of insomnia (CBT-i), information on the impact of light on wakefulness and sleep, information on napping and creating awareness on daytime sleepiness, tools for stress reduction, physical exercise, information on healthy eating in the context of shiftwork The education program will consist of a one-day, 8-hour session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention provided to the intervention group is based on evidence-based good standard of care and includes:
* Healthy scheduling (fast forward-rotating shift schedules adapted to chronotype, adequate resting times, napping, bright-light therapy)
* Education program for drivers (psychoeducation promoting sleep hygiene, cognitive-behavioral strategies, stress-management techniques, information on chronotherapy such as bright-light therapy and napping) Receives: Behavioral: Education program and ergonomic schedulling |
| Control group | No intervention | The control group will continue working according to the default shift schedules while being assigned to a waiting list in anticipation of the education program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleepiness as assessed with the Epworth Sleepiness Scale (ESS).
The Epworth Sleepiness Scale (ESS) is a validated self-report scale that gauges daytime sleepiness. The eight items of the ESS ask the respondent how likely (s)he is to doze off or fall asleep in different situations of everyday life. Total scores can range from 0 to 24 and ESS scores exceeding 9 are considered indicative of daytime sleepiness. A drop of 2,5 units will be considered a clinical minimally important difference.
Measured: Assessed at baseline and monthly up to and including the final 6-month evaluation and the statistical relevance of improvement (first to last score).
Secondary outcomes (11)
Effect on fatigue indices of the drivers as assessed with the CIS (Checklist Individual Strength). It is to be noted that fatigue and sleepiness are two distinct states of being that may be present or absent independently from each other, whe
The CIS (Checklist Individual Strength) The CIS is a validated, self-administered questionnaire assessing fatigue. It consists of 20 statements for which the respondent has to indicate on a 7-point Likert-scale to what extent the particular statement applies to him or her. The final score is obtained by adding the scores to all questions (range 20-140), where scores of 27 or higher are taken to indicate abnormal fatigue and scores ≥35 severe fatigue. Scores in excess of 76 have been associated with a high risk of chronic absenteeism in a working population. A drop of 10 units will be considered a clinical minimally important difference.
Measured: Evolution of CIS scores from baseline to three and six months and the statistical relevance of improvement (first to last score).
Sleep outcomes as evaluated by Total sleep time (TST) and sleep efficiency (SE)
As derived from self-recorded sleep-wake patterns by keeping a sleep-wake diary
Measured: Evolution at baseline, three and six months of mean total sleep time (TST) and sleep efficiency (SE)
Sleep outcomes measured as scores on the Pittsburgh Sleep Quality Index (PSQI).
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances. Although self-rated, the PSQI is widely used to assess sleep in sleep and shift-work research, where a global PSQI score >5 is indicative of poor sleep.
Measured: scores on the PSQI at baseline, three and six months and the statistical relevance of the baseline to 6-month change
General health-related quality of life (HR-QoL) as assessed with the SF-36
The SF-36 The SF-36 is one of the most widely used generic self-report measures of health-related quality of life and consists of 36 items that are structured into nine subscales. The scales are scored from 0-100 (transformed scale = (actual raw score - lowest possible raw score)/possible raw score range) x 100), with higher scores indicating better health.
Measured: evolution of total SF-36 scores from baseline to three and six months and the statistical relevance of first-to-last score improvement
Absenteeism: sick leave in terms of number of days off work due to illness will be derived from official records of and provided by the company
Absenteeism: formal data collected and provided by the company.
Measured: Data from baseline and after six months
Clinical health outcome: evolution of blood pressure as measured in mmHg
Normal blood pressure is defined as a value lower than 140/90 mmHg
Measured: Evolution of blood pressure from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of Body Mass Index (BMI) as measured in kg/m²
Normal BMI is defined as a value lower than 25 kg/m²
Measured: Evolution of BMI from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of fasting blood glucose as measured in mmol/l
Normal fasting blood glucose concentration according to the WHO is a value between 3.9 and 5.6 mmol/l
Measured: Evolution of fasting blood glucose from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of glycosylated hemoglobin (HbA1c) as measured in mmol/mol
On average, normal HbA1c for non-diabetics is < 36 mmol/mol
Measured: Evolution of HbA1c from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of high-sensitive C-reactive protein (hsCRP) measured in mg/L
High-sensitive C-reactive protein (hsCRP) is shown to be related to cardiovascular health. General guidelines for hsCRP scores: low risk of cardiovascular disease: less than 1.0 mg/L, average risk: 1.0 to 3.0 mg/L, high risk: above 3.0 mg/L
Measured: Evolution of hsCRP from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Mood and anxiety as gauged with the Hopkins Symptom Checklist (HSCL-25)
This self-administrated questionnaire helps to assess and measure anxiety and depression in multiple settings. Anxiety and depression show considerable overlap in primary-care populations and its brevity and self-report format makes the scale well-suited for use in the busy primary-care setting. The scale's 25 questions are divided into two subsections relating to the presence and intensity of symptoms of depression and anxiety as experienced during the previous week. The final score ranges from 1.00 to 4.00 and is calculated by dividing the sum of the scores of all items by 25. Generally, scores over 1.75 are taken to be indicative of a major depression.
Measured: Assessed at baseline and at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study startOct 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (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 Shift-work DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHIFTPLAN is a randomized controlled interventional trial. It can be situated in occupational health and field research. The drivers will be 1:1 randomized to either the intervention or the control group according to a parallel group design.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Filip Van Den Eede, MD, PhD, Study chair, Antwerp University Hospital (UZA). University of Antwerp (UA)Johan Verbraecken, MD, PhD, Study chair, Antwerp University Hospital (UZA). University of Antwerp (UA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452096
- Sponsor's protocol ID
- EDGE 000339
- Acronym
- SHIFTPLAN
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Declercq I, Van Den Eede F, Roelant E, Verbraecken J. SHIFTPLAN: a randomized controlled trial investigating the effects of a multimodal shift-work intervention on drivers' fatigue, sleep, health, and performance parameters. Trials. 2022 Aug 17;23(1):662. doi: 10.1186/s13063-022-06573-6.
PubMed 35978435
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating the Effects of a Multimodal Shift-work Intervention on Drivers' Fatigue, Sleep, Health and Performance Parameters.
- ClinicalTrials.gov ID
- NCT05452096
- Acronym / sponsor ID
- SHIFTPLAN / EDGE 000339
- Conditions
- Shift-work Disorder, Insomnia, Fatigue, Mental Health Issue, Quality of Life, Coping Skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- Oct 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 11 Jul 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.
Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Epidemiological data show that shift workers are at increased risk of sleepiness, fatigue and insomnia, cardiovascular disease, breast cancer and shift-work disorder. Prevalence estimates of shift-work disorder vary between 5% and 26,5%.
Given these widespread and serious health and functional consequences of shift work, there is a necessity for treatments that improve shift workers' health and work performance. Most non-pharmacological recommendations mention improved scheduling, bright-light exposure, napping, psychoeducation fostering sleep hygiene, and cognitive-behavioral interventions.
The effects of shift work on the health, fatigue and sleepiness of drivers have been robustly investigated in observational studies, as well as the effects of single measures such as scheduling or resting times. But studies on the effectiveness of countermeasures against the adverse impact of shift work are sparse, especially for high-risk populations such as professional drivers and controlled intervention studies are lacking. Several other investigators expounded the need for a multi-level approach to managing occupational sleep-related fatigue and workplace interventions to promote sleep and health of shift workers. Highlighting the high public-health burden associated with lack of recuperative sleep, the authors pointed out the pressing need to develop policies and implement programs aimed at improving workers' sleep health.
With SHIFTPLAN, the investigators aim to fill this gap in comprehensive approaches. To their knowledge, this is the first randomised controlled trial to systematically gauge the effect of a multimodal program that includes ergonomic shift scheduling and an educational program on well-defined health, sleep and performance outcomes in professional drivers.
Detailed description
The duration of the intervention will be six months. The intervention provided to the intervention group is based on evidence-based good standard of care and includes: 1) Healthy scheduling (fast forward-rotating shift schedules adapted to chronotype, adequate resting times, napping, bright-light therapy); 2) Education program for drivers (psychoeducation promoting sleep hygiene, cognitive-behavioral strategies, stress-management techniques, information on chronotherapy such as bright-light therapy and napping) The control group or "waiting-list group" will include drivers who will continue working according to the default shift schedules while being assigned to a waiting list in anticipation of the education program to which they will able to suscribe after completing the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHIFTPLAN is a randomized controlled interventional trial. It can be situated in occupational health and field research. The drivers will be 1:1 randomized to either the intervention or the control group according to a parallel group design.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Education program and ergonomic schedullingThe intervention provided to the intervention group is based on evidence-based good standard of care and includes: * Healthy scheduling (fast forward-rotating shift schedules adapted to chronotype, adequate resting times, napping, bright-light therapy) * Education program for drivers (psychoeducation promoting sleep hygiene, cognitive-behavioral strategies, stress-management techniques, information on chronotherapy such as bright-light therapy and napping) |
| Control group | No intervention | –The control group will continue working according to the default shift schedules while being assigned to a waiting list in anticipation of the education program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- - Professional drivers having worked in shifts with the transport company in full-time or ≥80% part-time employment in the company's regular backward-rotating schedule for at least two years.
Key exclusion criteria (6 listed)
- Regular medication for high blood pressure and uncontrolled high blood pressure (defined as exceeding 140/90 mmHg) at screening, regular medication for diabetes, sleeping pills or sedative medication for depression (defined as trazodone, mirtazapine and amitriptyline). Because our secondary outcomes imply the evolution of blood-pressure and blood-sugar parameters, drivers with such pre-existing controlled or non-controlled comorbidity will not be eligible for participation.
- High risk of moderate-to-severe obstructive sleep apnea syndrome (OSAS) as assessed with the STOP-Bang questionnaire, a simple, easy to remember and self-reportable screening tool. We will use a cut-off score of 6 or higher to indicate the presence of OSAS.
- Drivers combining their job as a professional driver with another job elsewhere.
- Excessive sleepiness as defined as a score in excess of 12 on the Epworth Sleepiness Scale (ESS). Although the habitual cut-off is >9, we opted for this higher threshold because we will be examining the effect of the intervention on daytime sleepiness. All applicants with an ESS >12 will be excluded and referred to a general practitioner for further evaluation.
- A BMI higher than 35. We chose this cut-off value based on the data provided by the external occupational health service, which showed that in 2018, 42.6 % of their drivers had a mean BMI of 25-30 and 27.5 % a BMI between 30-40.
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 |
|---|---|---|
| Education program and ergonomic schedullingThe duration: six months. The explicit choice for a multimodal intervention to be tested as a whole is in line with the assertion of other experts that workplace interventions using a single approach will not be effective. Multimodal intervention 1. Implementing healthy scheduling. This will imply fast forward-rotating shift schedules, being adapted to chronotype, allowing for adequate resting times between shifts and series of shifts, allowing for napping at work, in particular during the first two days of an early shift. 2. Education program for drivers: psychoeducation on the sleep-wake cycle chronotypes, based on the cognitive-behavioral treatment of insomnia (CBT-i), information on the impact of light on wakefulness and sleep, information on napping and creating awareness on daytime sleepiness, tools for stress reduction, physical exercise, information on healthy eating in the context of shiftwork The education program will consist of a one-day, 8-hour session. | Behavioural | Intervention group |
Primary outcome
Change in sleepiness as assessed with the Epworth Sleepiness Scale (ESS).
Time frame: Assessed at baseline and monthly up to and including the final 6-month evaluation and the statistical relevance of improvement (first to last score).
The Epworth Sleepiness Scale (ESS) is a validated self-report scale that gauges daytime sleepiness. The eight items of the ESS ask the respondent how likely (s)he is to doze off or fall asleep in different situations of everyday life. Total scores can range from 0 to 24 and ESS scores exceeding 9 are considered indicative of daytime sleepiness. A drop of 2,5 units will be considered a clinical minimally important difference.
11 secondary outcomes
Effect on fatigue indices of the drivers as assessed with the CIS (Checklist Individual Strength). It is to be noted that fatigue and sleepiness are two distinct states of being that may be present or absent independently from each other, whe
Time frame: Evolution of CIS scores from baseline to three and six months and the statistical relevance of improvement (first to last score).
Sleep outcomes as evaluated by Total sleep time (TST) and sleep efficiency (SE)
Time frame: Evolution at baseline, three and six months of mean total sleep time (TST) and sleep efficiency (SE)
Sleep outcomes measured as scores on the Pittsburgh Sleep Quality Index (PSQI).
Time frame: scores on the PSQI at baseline, three and six months and the statistical relevance of the baseline to 6-month change
General health-related quality of life (HR-QoL) as assessed with the SF-36
Time frame: evolution of total SF-36 scores from baseline to three and six months and the statistical relevance of first-to-last score improvement
Absenteeism: sick leave in terms of number of days off work due to illness will be derived from official records of and provided by the company
Time frame: Data from baseline and after six months
Clinical health outcome: evolution of blood pressure as measured in mmHg
Time frame: Evolution of blood pressure from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of Body Mass Index (BMI) as measured in kg/m²
Time frame: Evolution of BMI from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of fasting blood glucose as measured in mmol/l
Time frame: Evolution of fasting blood glucose from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of glycosylated hemoglobin (HbA1c) as measured in mmol/mol
Time frame: Evolution of HbA1c from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Clinical health outcome: evolution of high-sensitive C-reactive protein (hsCRP) measured in mg/L
Time frame: Evolution of hsCRP from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
Mood and anxiety as gauged with the Hopkins Symptom Checklist (HSCL-25)
Time frame: Assessed at baseline and at six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 35978435Declercq I, Van Den Eede F, Roelant E, Verbraecken J. SHIFTPLAN: a randomized controlled trial investigating the effects of a multimodal shift-work intervention on drivers' fatigue, sleep, health, and performance parameters. Trials. 2022 Aug 17;23(1):662. doi: 10.1186/s13063-022-06573-6.
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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.
Filip Van Den Eede, MD, PhD study chair
Antwerp University Hospital (UZA). University of Antwerp (UA)
Johan Verbraecken, MD, PhD study chair
Antwerp University Hospital (UZA). University of Antwerp (UA)
Questions about this trial
What is this clinical trial studying?
A study testing Education program and ergonomic schedulling in people with Shift-work Disorder and Insomnia, run by University Hospital, Antwerp.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inge Declercq, MD (+3238213938 ext. 4331, inge.declercq@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleepiness as assessed with the Epworth Sleepiness Scale (ESS). (time frame: Assessed at baseline and monthly up to and including the final 6-month evaluation and the statistical relevance of improvement (first to last score).). 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 NCT05452096, 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 Jul 2022.