Chronic Renal FailureLUMIDIALNCT04089397
Light Therapy on Sleep Quality in Dialysis Patients
A study testing Light Therapy in people with Chronic Renal Failure and Sleep Disorder, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
Sleep disorders are common in dialysis patients. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure, Sleep Disorder, Hemodialysis
- What is being tested?
- Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 11 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient in conventional hemodialysis or hemodiafiltration for at least 3 months
- Patient requiring a dialysis session three times a week in the investigational site
- Patient benefiting from a social security scheme
- Patient informed and having given his free and informed consent to participate in the study
Who cannot join
- Patient with binocular blindness and / or age-related macular degeneration
- Eye fatigue
- Patient who has undergone a recent eye surgery (less than 3 months) or for whom such an operation is planned in the next 20 weeks
- Patient taking medications known to be responsible for photosensitivity
- Pregnant or lactating woman
- Patient under guardianship or curatorship
Show all 10Show fewer
- Patient unable to give free and informed consent
- Wishes of the patient or the physician
- Appearance of unexplained visual disturbances
- Kidney transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Open-label Trial Evaluating Light Therapy on Sleep Quality in Dialysis Patients
Sleep disorders are common in dialysis patients. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.
Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin.
Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.
Read the detailed description
Sleep disorders are common in dialysis patients. Indeed, several studies have reported that the prevalence of these disorders is higher than that of the general population. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.
Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin. Light therapy has been studied in several pathologies. In the context of renal insufficiency, only one randomized study was conducted in renal transplant patients: out of 30 patients, the effect of light therapy regained an 11-minute increase in sleep latency, an earlier awakening of 24 minutes, and a gain in the DASS-21 depression score of 1.7 points while there was no improvement in his three parameters in the control group. Interest in light therapy has also been evaluated in seasonal and non-seasonal depression. In a meta-analysis of 458 patients, light therapy adjuvant use was as effective as the addition of a second molecule.
Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.
We therefore wish to set up a clinical study to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients. The secondary objectives will be to specify the improved sleep parameters, to evaluate the impact on the anxious-depressive score, the arterial hypertension, and the nutritional state, and the residual effect of light therapy.
The aim of this trial is to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients.
- Conditions
- Chronic Renal Failure, Sleep Disorder, Hemodialysis, Light Therapy
- Being tested
- Light Therapy
- Keywords
- light therapy in sleep disorders of dialysis patients
- Medical subject headings
- Kidney Failure, Chronic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light TherapyDevice
Also called Lumie Brazil® (light therapy device for the treatment of seasonal affective disorders)
Five weeks of light therapy, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis
| Study group | Role | What they receive |
|---|---|---|
| Light therapy group | Experimental | Five weeks of light therapy, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis (at home, for patients dialyzing the afternoon, or during dialysis for patients dialyzing in the morning) Receives: Device: Light Therapy |
| Control group | No intervention | Usual care, without light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of light therapy on the quality of sleep of dialysis patients
The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
The primary endpoint is the measured difference in PSQI score between baseline and 5 weeks post-exposure to light therapy between the two arms of the study (no light therapy versus active light therapy).
Measured: 5 weeks
Secondary outcomes (10)
Pathological sleep disorders defined by PSQI score > 5
Percentage of patients with a PSQI score > 5 measured in both arms at baseline and after 5 weeks
Measured: 5 weeks
Analysis of each component of the PSQI score
There are 7 components in the PSQI score (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction.
Difference of the medians obtained on each component of the PSQI score in both arms at baseline and after 5 weeks
Measured: 5 weeks
Anxious-depressive state of the patients
The French Depression Anxiety Stress Scales (DASS 21) is a 21-item self-rated questionnaire designed to measure the emotional states of depression, anxiety and stress over the past week. The scale to which each item belongs is indicated by the letter D (Depression), A (Anxiety) and S (Stress). For each scale, scores are summed with the higher scores corresponding to the most severe status.
Total score difference obtained from the questionnaire French Depression Anxiety Stress Scales (DASS 21) in both arms at baseline and after 5 weeks
Measured: 5 weeks
Impact of light therapy on nutritional intake of patients
The normalized protein catabolic rate is a formula commonly used to assess dietary protein intake in dialysis patients, as a means towards determining nutritional adequacy.
Absolute difference in Normalized Protein Catabolic Rate value in both arms at baseline, after 5 weeks and 10 weeks
Measured: 10 weeks
Systolic Blood Pressure values
Absolute difference in systolic blood pressure in both arms at baseline, after 5 weeks and 10 weeks
Measured: 10 weeks
Diastolic Blood Pressure values
Absolute difference in diastolic blood pressure in both arms at baseline, after 5 weeks and 10 weeks
Measured: 10 weeks
Side effects of light therapy
Number and frequency of side effects
Measured: 5 weeks
Impact of home care on the effectiveness of the primary endpoint
The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Difference in the average PSQI score between the two subgroups: home care versus during dialysis light therapy
Measured: 5 weeks
Evaluation of the residual duration of the effect of light therapy on sleep disorder
The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Average difference in PSQI score at the end of the procedure and 5 weeks later.
Measured: 5 weeks
Evaluation of the residual duration of the effect of light therapy on anxious-depressive state of the patients
The French Depression Anxiety Stress Scales (DASS 21) is a 21-item self-rated questionnaire designed to measure the emotional states of depression, anxiety and stress over the past week. The scale to which each item belongs is indicated by the letter D (Depression), A (Anxiety) and S (Stress). For each scale, scores are summed with the higher scores corresponding to the most severe status.
Average difference in DASS 21 score, at the end of the procedure and 5 weeks later.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Oct 2019
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- Randomized open-label trial
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Franko, MD, Principal investigator, CH Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089397
- Sponsor's protocol ID
- 17-11-LUMIDIAL
- Other IDs
- 2018-A02276-49
- Acronym
- LUMIDIAL
- Status last verified
- Nov 2019
- First submitted
- 11 Sep 2019
- Last updated
- 2 Dec 2020
- 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 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Trial Evaluating Light Therapy on Sleep Quality in Dialysis Patients
- ClinicalTrials.gov ID
- NCT04089397
- Acronym / sponsor ID
- LUMIDIAL / 17-11-LUMIDIAL
- Conditions
- Chronic Renal Failure, Sleep Disorder, Hemodialysis, Light Therapy
- Keywords
- light therapy in sleep disorders of dialysis patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 13 Sep 2019 (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 are common in dialysis patients. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.
Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin.
Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.
Detailed description
Sleep disorders are common in dialysis patients. Indeed, several studies have reported that the prevalence of these disorders is higher than that of the general population. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.
Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin. Light therapy has been studied in several pathologies. In the context of renal insufficiency, only one randomized study was conducted in renal transplant patients: out of 30 patients, the effect of light therapy regained an 11-minute increase in sleep latency, an earlier awakening of 24 minutes, and a gain in the DASS-21 depression score of 1.7 points while there was no improvement in his three parameters in the control group. Interest in light therapy has also been evaluated in seasonal and non-seasonal depression. In a meta-analysis of 458 patients, light therapy adjuvant use was as effective as the addition of a second molecule.
Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.
We therefore wish to set up a clinical study to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients. The secondary objectives will be to specify the improved sleep parameters, to evaluate the impact on the anxious-depressive score, the arterial hypertension, and the nutritional state, and the residual effect of light therapy.
The aim of this trial is to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open-label trial
| Arm | Type | Receives |
|---|---|---|
| Light therapy group | Experimental | Device: Light TherapyFive weeks of light therapy, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis (at home, for patients dialyzing the afternoon, or during dialysis for patients dialyzing in the morning) |
| Control group | No intervention | –Usual care, without light therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient in conventional hemodialysis or hemodiafiltration for at least 3 months
- Patient requiring a dialysis session three times a week in the investigational site
- Patient benefiting from a social security scheme
- Patient informed and having given his free and informed consent to participate in the study
Key exclusion criteria (10 listed)
- Patient with binocular blindness and / or age-related macular degeneration
- Eye fatigue
- Patient who has undergone a recent eye surgery (less than 3 months) or for whom such an operation is planned in the next 20 weeks
- Patient taking medications known to be responsible for photosensitivity
- Pregnant or lactating woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light TherapyAlso: Lumie Brazil® (light therapy device for the treatment of seasonal affective disorders)Five weeks of light therapy, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis | Device | Light therapy group |
Primary outcome
Impact of light therapy on the quality of sleep of dialysis patients
Time frame: 5 weeks
The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. The primary endpoint is the measured difference in PSQI score between baseline and 5 weeks post-exposure to light therapy between the two arms of the study (no light therapy versus active light therapy).
10 secondary outcomes
Pathological sleep disorders defined by PSQI score > 5
Time frame: 5 weeks
Analysis of each component of the PSQI score
Time frame: 5 weeks
Anxious-depressive state of the patients
Time frame: 5 weeks
Impact of light therapy on nutritional intake of patients
Time frame: 10 weeks
Systolic Blood Pressure values
Time frame: 10 weeks
Diastolic Blood Pressure values
Time frame: 10 weeks
Side effects of light therapy
Time frame: 5 weeks
Impact of home care on the effectiveness of the primary endpoint
Time frame: 5 weeks
Evaluation of the residual duration of the effect of light therapy on sleep disorder
Time frame: 5 weeks
Evaluation of the residual duration of the effect of light therapy on anxious-depressive state of the patients
Time frame: 5 weeks
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 2 Dec 2020.
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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.
Benoit Franko, MD principal investigator
CH Annecy Genevois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Therapy in people with Chronic Renal Failure and Sleep Disorder, run by Centre Hospitalier Annecy Genevois at 1 site in France.
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 10 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 2 Dec 2020. 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 France. 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?
Impact of light therapy on the quality of sleep of dialysis patients (time frame: 5 weeks). 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 2 Dec 2020.