InsomniaON TIMENCT06613958
Older Adults Exercising On Time
A study testing Physical activity timing in people with Insomnia and Circadian Rhythm Disorders, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
There are indications from epidemiological cohort studies and animal experiments that timing of physical activity (also referred as "chronoactivity"), irrespective of intensity, impacts health and disease. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Circadian Rhythm Disorders
- What is being tested?
- Physical activity timing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 May 2024to 27 Jun 2024
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 60 and 80 years old
- Retired
- Long lasting sleep problems (as assessed by a the screening questionnaire administered telephonically and by the ISI which will be filled out during the screening visit)
- Access to and ability to use a smart phone (Android or Apple)
Who cannot join
- Currently employed or working
- Extreme sleep chronotypes (measured by the Munich chronotype questionnaire)
- Participation in any sort of fasting regimen (e.g. intermitted fasting or Ramadan)
- Experienced recent (<6 months) adverse life events (e.g., death of partner)
- Abnormal values in glucose metabolism, thyroid, liver or kidney function, or inflammation markers that after examination of the study doctor need immediate attention of a general practitioner or specialist.
- Diagnosed clinical depression
Show all 13Show fewer
- Diagnosed neurodegenerative diseases (e.g. dementia or Parkinson's disease)
- Diagnosed sleep apnoea
- Diagnosed restless legs syndrome
- Use of beta-adrenergic blocking agents
- Use of sleep medication*
- Injuries or other severe physical conditions (such as active arthrosis) that inhibits physical activity
- Travelled across time zones one week prior to start of study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
There are indications from epidemiological cohort studies and animal experiments that timing of physical activity (also referred as "chronoactivity"), irrespective of intensity, impacts health and disease. In view of the detrimental effects of circadian misalignment, the large group of older people suffering from sleep problems, and the seeming importance of chronoactivity, the investigators will perform a randomised cross-over study that aims to uncover the effect of timing of physical activity on insomnia severity and related(circadian) health parameters in older adults with self-reported sleep problems. Here, the investigators hypothesize that timing of physical activity has a beneficial impact on insomnia symptoms and on circadian rhythms of additional health parameters (e.g., metabolic, psychosocial) in older people. To study this research hypothesis, the investigators will examine the effect of physical activity timing on insomnia severity in older adults with self-reported sleep problems. In addition, the investigators will examine the effect of physical activity timing on exploratory rhythmic parameters of biological clock function, physiology and metabolism, mental health, behavioural factors, and immune and cell signalling functions. For this study, a two-armed randomised cross-over study, Dutch speaking older adults between 60 and 80 years old (male and female) and having sleep problems (insomnia severity index>10 points) from the general population in the Netherlands will be selected as participants for this study. Participants will perform one sedentary period and two period of increased physical activity with different daily patterns: 1)active morning; 2) active evening with a duration of 14 days each. In both active intervention arms, participants will follow an exercise program containing outdoor physical exercise sessions (Vitality Club) containing endurance and strength exercises, relative rest days of 30 minutes light intensity physical activity, and one Active@Home program; a 1-hour training session of various moderate to vigorous activities. The training sessions will be held either in the morning or evening (depending on the intervention arm) and will be one hour long. Study outcomes will be compared between the different intervention groups.
- Conditions
- Insomnia, Circadian Rhythm Disorders
- Being tested
- Physical activity timing
- Keywords
- Chronoactivity, Sleep, Circadian rhythm, Exercise timing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity timingBehavioural
Also called Active morning (exercise program from 10:00 - 11:00 in the morning), Active evening (exercise program from 19:30 - 20:30 in the evening), Sedentary period (no exercise)
The investigators will compare our interventions to a 14-day period of sedentary behavior, during which the participant will refrain from any moderate to vigorous exercise. Next, participants will participate in two interventions consisting each of a 14-day physical activity regimen. The active morning and active evening interventions are equal in content. Both groups will be instructed to refrain from any moderate to vigorous exercise for the rest of the day. Per intervention, a total of eight Vitality Club training session comprising of a combination of aerobic endurance training and resistance exercise training will be given by a trained sports coach or physical therapist specialized in geriatric physical therapy. During the weekends, participants will be asked to perform a 'relative rest' session with some light activity during the training time window of the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Order of interventions: Sedentary - Active morning - Active Evening Receives: Behavioral: Physical activity timing |
| Group 2 | Other | Order of the interventions: Sedentary - Active Evening - Active Morning Receives: Behavioral: Physical activity timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Score on Insomnia Severity Index (ISI). Participants will be asked to fill out the ISI questionnaire (Dutch version) The ISI questionnaire consists of 7 questions and outcomes include: 'No clinically significant insomnia (0-7 points)', 'Subthreshold insomnia (8-14 points)', 'Moderate severity clinical insomnia (15-21 point), and 'Severe clinical insomnia (22-28 points)'.
Measured: 4 times in total: at baseline T-3 (T= week), at T2 , T5, and at T8 (endline).
Secondary outcomes (16)
Dim light melatonin onset (DLMO)
Participants will be asked to perform/collect 7 buccal swabs in a time range of 5 hours prior to bedtime to 1 hour after bedtime to measure the melatonin pattern DLMO one evening at the end of each intervention. This measurement will be done according to the standard protocol from Chrono@Work (Groningen, The Netherlands) in dim light conditions. Participants will be carefully instructed beforehand on the procedure. Melatonin levels will be shown in Pg/ml
Measured: 3 times in total: two weeks, five weeks and eight weeks after baseline.
Ecological monitoring assessment
During the measurement week, participants will be asked to fill out the eEMA questionnaire in the Leuven mPath app 4 times a day on set times (between 7-9 AM, 12-2 PM, 4-6 PM and 8-10 PM). Participants will receive a pop-up on their smartphones and will have a window of 2 hours to fill in the questionnaire. The questionnaire consists of multiple questions that gather information on current mood/feelings divided into multiple dimensions: positive affectivity, negative affectivity, energetic arousal and cognition. A visual analogue scale will be used to answer the questions. To minimize the burden of this repeated questionnaire, the time needed to fill out the questionnaire is limited to approximately 3 minutes.
Measured: 3 periods in total of one week each: the second week, the fifth week and the eighth week.
Sleep quality - sleep duration
Objective sleep quality will be monitored with the Withings Sleep Analyzer (Withings, Issy-les-Moulineaux, France) . Prior to the study, the Withings Sleep Analyzer will be installed in the participants bed. A smart phone is required to set-up the device and the devices must be connected to a Wi-Fi to be able to send data to the cloud. After set-up no link to the smartphone is required. The device must be connected to power.
Sleep duration, pattern of and duration spent in different sleep stages (deep, REM, and light sleep), sleep latency, sleep efficiency, and sleep regularity.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep latency
Objective sleep quality will be monitored with the Withings Sleep Analyzer (Withings, Issy-les-Moulineaux, France) . Prior to the study, the Withings Sleep Analyzer will be installed in the participants bed. A smart phone is required to set-up the device and the devices must be connected to a Wi-Fi to be able to send data to the cloud. After set-up no link to the smartphone is required. The device must be connected to power.
Sleep duration, pattern of and duration spent in different sleep stages (deep, REM, and light sleep), sleep latency, sleep efficiency, and sleep regularity.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep stages
Objective sleep quality will be monitored with the Withings Sleep Analyzer (Withings, Issy-les-Moulineaux, France) . Prior to the study, the Withings Sleep Analyzer will be installed in the participants bed. A smart phone is required to set-up the device and the devices must be connected to a Wi-Fi to be able to send data to the cloud. After set-up no link to the smartphone is required. The device must be connected to power.
Sleep duration, pattern of and duration spent in different sleep stages (deep, REM, and light sleep), sleep latency, sleep efficiency, and sleep regularity.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep efficiency
Objective sleep quality will be monitored with the Withings Sleep Analyzer (Withings, Issy-les-Moulineaux, France) . Prior to the study, the Withings Sleep Analyzer will be installed in the participants bed. A smart phone is required to set-up the device and the devices must be connected to a Wi-Fi to be able to send data to the cloud. After set-up no link to the smartphone is required. The device must be connected to power.
Sleep duration, pattern of and duration spent in different sleep stages (deep, REM, and light sleep), sleep latency, sleep efficiency, and sleep regularity.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep regularity
Objective sleep quality will be monitored with the Withings Sleep Analyzer (Withings, Issy-les-Moulineaux, France) . Prior to the study, the Withings Sleep Analyzer will be installed in the participants bed. A smart phone is required to set-up the device and the devices must be connected to a Wi-Fi to be able to send data to the cloud. After set-up no link to the smartphone is required. The device must be connected to power.
Sleep duration, pattern of and duration spent in different sleep stages (deep, REM, and light sleep), sleep latency, sleep efficiency, and sleep regularity.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Biological assessment: clock gene expression
Paxgene 1x 2.5 ml 7,5 ml RNA Gene expression clock genes (in batch)
Measured: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: metabolomics
EDTA 1x 2 ml 6 ml plasma Metabolomics (in batch)
Measured: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: proteomics
EDTA 1x 2 ml 6 ml plasma proteomics (in batch)
Measured: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: glucose metabolism
EDTA 1x 2 ml 2 ml plasma HbA1c, Insulin, glucose,
Measured: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: biomarkers for inflammation, thyroid, kidney and liver function
Serum 1x 3.5 ml 14 ml serum eGRF/creatinin, Hs-CRP, Gamma GT, ASAT, ALAT, TSH, ft4 (in batch)
Measured: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Food capturing
Participants will log their daily food intake during each measurement week by using a food diary that will be distributed prior to the start of the study. Frequency and timing of food intake will be assessed.
Measured: 3 periods in total of one week each: week two, week five, and at week eight.
Heart rate
Participants will wear the Corsano Cardiowatch 287-2 (Corsano Health, The Hague, the Netherlands) wrist band on their right wrist continuously during the study period. The wristband is multifunctional and is waterproof. Participants will wear the wrist band 24 hours a day. The HR is measured using a PPG (photoplethysmogram, i.e., optically obtained volumetric measurement) and ECG. The manufacturer supplies the algorithm for converting the PPG/ECG signals into a set of HR values. All data from the Cardiowatch is available real time and is transferred from the watch to the smartphone using a clinical trial app, developed by the provider, which allows the researcher to retrieve live vital sign data while conducting a blinded study.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Heart rate variability
Participants will wear the Corsano Cardiowatch 287-2 (Corsano Health, The Hague, the Netherlands) wrist band on their right wrist continuously during the study period. The wristband is multifunctional and is waterproof. Participants will wear the wrist band 24 hours a day. The HR is measured using a PPG (photoplethysmogram, i.e., optically obtained volumetric measurement) and ECG. The manufacturer supplies the algorithm for converting the PPG/ECG signals into a set of HR values. All data from the Cardiowatch is available real time and is transferred from the watch to the smartphone using a clinical trial app, developed by the provider, which allows the researcher to retrieve live vital sign data while conducting a blinded study.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Core body temperature
Core body temperature will be continuously measured by the Cardiowatch 287-2 in degrees Celcius. This parameter will be derived through an algorhythm of combined data from Heatflux sensor and PPG signal. Diurnal patterns of core body temperature as well as the time of lowest daily temperature will be derived from this data.
Measured: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start2 May 2024
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will perform a randomized two-armed cross-over study. Both groups will start with the sedentary period. Depending on the intervention arm, participants will then undergo the active morning intervention or active evening intervention first, followed by the other intervention. There will be a total of two washout periods both lasting 7 days, one between the sedentary period and first intervention and one between the first and second intervention to prevent or minimize 'carry over' of previous intervention effect. The two interventions and the sedentary period will last 14 days each and contain a 'calibration period' (7 days) and a 'measurement week' (7 days). The total study duration will be 8 weeks and the study will largely take place at the participants' home except for the training sessions (Vitality Clubs) that will take place at an outdoor sports facility in the municipality of Leiden and the study site visits which will take place in the LUMC.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation of Scientific Research (NWO), Centre for Human Drug Research, Netherlands, Chrono@Work, Corsano Health B.V., M-Path Leuven
- Responsible party
- Principal investigator, dvanheemst, Leiden University Medical Center
- Investigators
- Diana van Heemst, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613958
- Sponsor's protocol ID
- NL82335.058.22
- Acronym
- ON TIME
- Status last verified
- Sep 2024
- First submitted
- 12 Mar 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older Adults Exercising On Time
- ClinicalTrials.gov ID
- NCT06613958
- Acronym / sponsor ID
- ON TIME / NL82335.058.22
- Conditions
- Insomnia, Circadian Rhythm Disorders
- Keywords
- Chronoactivity, Sleep, Circadian rhythm, Exercise timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation of Scientific Research (NWO), Centre for Human Drug Research, Netherlands, Chrono@Work, Corsano Health B.V., M-Path Leuven
- Study start
- 2 May 2024 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 26 Sep 2024 (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.
There are indications from epidemiological cohort studies and animal experiments that timing of physical activity (also referred as "chronoactivity"), irrespective of intensity, impacts health and disease. In view of the detrimental effects of circadian misalignment, the large group of older people suffering from sleep problems, and the seeming importance of chronoactivity, the investigators will perform a randomised cross-over study that aims to uncover the effect of timing of physical activity on insomnia severity and related(circadian) health parameters in older adults with self-reported sleep problems. Here, the investigators hypothesize that timing of physical activity has a beneficial impact on insomnia symptoms and on circadian rhythms of additional health parameters (e.g., metabolic, psychosocial) in older people. To study this research hypothesis, the investigators will examine the effect of physical activity timing on insomnia severity in older adults with self-reported sleep problems. In addition, the investigators will examine the effect of physical activity timing on exploratory rhythmic parameters of biological clock function, physiology and metabolism, mental health, behavioural factors, and immune and cell signalling functions. For this study, a two-armed randomised cross-over study, Dutch speaking older adults between 60 and 80 years old (male and female) and having sleep problems (insomnia severity index>10 points) from the general population in the Netherlands will be selected as participants for this study. Participants will perform one sedentary period and two period of increased physical activity with different daily patterns: 1)active morning; 2) active evening with a duration of 14 days each. In both active intervention arms, participants will follow an exercise program containing outdoor physical exercise sessions (Vitality Club) containing endurance and strength exercises, relative rest days of 30 minutes light intensity physical activity, and one Active@Home program; a 1-hour training session of various moderate to vigorous activities. The training sessions will be held either in the morning or evening (depending on the intervention arm) and will be one hour long. Study outcomes will be compared between the different intervention groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will perform a randomized two-armed cross-over study. Both groups will start with the sedentary period. Depending on the intervention arm, participants will then undergo the active morning intervention or active evening intervention first, followed by the other intervention. There will be a total of two washout periods both lasting 7 days, one between the sedentary period and first intervention and one between the first and second intervention to prevent or minimize 'carry over' of previous intervention effect. The two interventions and the sedentary period will last 14 days each and contain a 'calibration period' (7 days) and a 'measurement week' (7 days). The total study duration will be 8 weeks and the study will largely take place at the participants' home except for the training sessions (Vitality Clubs) that will take place at an outdoor sports facility in the municipality of Leiden and the study site visits which will take place in the LUMC.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Behavioral: Physical activity timingOrder of interventions: Sedentary - Active morning - Active Evening |
| Group 2 | Other | Behavioral: Physical activity timingOrder of the interventions: Sedentary - Active Evening - Active Morning |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 60 and 80 years old
- Retired
- Long lasting sleep problems (as assessed by a the screening questionnaire administered telephonically and by the ISI which will be filled out during the screening visit)
- Access to and ability to use a smart phone (Android or Apple)
Key exclusion criteria (13 listed)
- Currently employed or working
- Extreme sleep chronotypes (measured by the Munich chronotype questionnaire)
- Participation in any sort of fasting regimen (e.g. intermitted fasting or Ramadan)
- Experienced recent (<6 months) adverse life events (e.g., death of partner)
- Abnormal values in glucose metabolism, thyroid, liver or kidney function, or inflammation markers that after examination of the study doctor need immediate attention of a general practitioner or specialist.
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 |
|---|---|---|
| Physical activity timingAlso: Active morning (exercise program from 10:00 - 11:00 in the morning), Active evening (exercise program from 19:30 - 20:30 in the evening), Sedentary period (no exercise)The investigators will compare our interventions to a 14-day period of sedentary behavior, during which the participant will refrain from any moderate to vigorous exercise. Next, participants will participate in two interventions consisting each of a 14-day physical activity regimen. The active morning and active evening interventions are equal in content. Both groups will be instructed to refrain from any moderate to vigorous exercise for the rest of the day. Per intervention, a total of eight Vitality Club training session comprising of a combination of aerobic endurance training and resistance exercise training will be given by a trained sports coach or physical therapist specialized in geriatric physical therapy. During the weekends, participants will be asked to perform a 'relative rest' session with some light activity during the training time window of the intervention arm. | Behavioural | Group 1, Group 2 |
Primary outcome
Insomnia severity
Time frame: 4 times in total: at baseline T-3 (T= week), at T2 , T5, and at T8 (endline).
Score on Insomnia Severity Index (ISI). Participants will be asked to fill out the ISI questionnaire (Dutch version) The ISI questionnaire consists of 7 questions and outcomes include: 'No clinically significant insomnia (0-7 points)', 'Subthreshold insomnia (8-14 points)', 'Moderate severity clinical insomnia (15-21 point), and 'Severe clinical insomnia (22-28 points)'.
16 secondary outcomes
Dim light melatonin onset (DLMO)
Time frame: 3 times in total: two weeks, five weeks and eight weeks after baseline.
Ecological monitoring assessment
Time frame: 3 periods in total of one week each: the second week, the fifth week and the eighth week.
Sleep quality - sleep duration
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep latency
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep stages
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep efficiency
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Sleep quality - sleep regularity
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Biological assessment: clock gene expression
Time frame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: metabolomics
Time frame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: proteomics
Time frame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: glucose metabolism
Time frame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Biological assessment: biomarkers for inflammation, thyroid, kidney and liver function
Time frame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
Food capturing
Time frame: 3 periods in total of one week each: week two, week five, and at week eight.
Heart rate
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Heart rate variability
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Core body temperature
Time frame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
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 26 Sep 2024.
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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.
Diana van Heemst, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity timing in people with Insomnia and Circadian Rhythm Disorders, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 13 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 26 Sep 2024. 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 Netherlands. 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?
Insomnia severity (time frame: 4 times in total: at baseline T-3 (T= week), at T2 , T5, and at T8 (endline).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2024.