Diabetes Mellitus, Type 2NCT04918004
The Effect of Sleep hygıene traınıng on Blood Sugar regulatıon
A study testing Sleep Hygiene in people with Diabetes Mellitus, Type 2 and Sleep Hygiene, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although many studies have shown an inverse relationship between blood glucose regulation and sleep hygiene, recommendations for improving sleep hygiene have not yet been included in diabetes treatment guidelines. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Sleep Hygiene
- What is being tested?
- Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 30 Nov 2018
- 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
- Patients who were admitted to our clinic with the diagnosis of diabetes mellitus type 2 during the study
Who cannot join
- Patients with a known sleep disorder,
- Language or psychiatric problems that prevented responding to the questionnaire
- Patients who underwent changes in their antidiabetic treatment during the first control examination
- Those who did not re-admit to the hospital for routine check-ups within 6 months after the first visit
- Patients who declared not to comply with the recommendations were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey Ankara Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, Altındağ, 06110
About this study
Official title: The Effect of Sleep hygıene traınıng gıven to patıents wıth dıabetes mellıtus on Blood Sugar regulatıon: a randomızed Controlled Study
Although many studies have shown an inverse relationship between blood glucose regulation and sleep hygiene, recommendations for improving sleep hygiene have not yet been included in diabetes treatment guidelines. In this study, it was aimed to reveal with a randomized controlled study whether training on sleep hygiene will have an effect on blood glucose regulation of Type 2 diabetes patients. Case and control groups will be formed by random sampling method. Pıttsburgh sleep quality index will be applied face to face and HbA1c values will be recorded for all patients included in the study. In addition, sleep hygiene training will be given to the case group. Among the patients included in the study, the second HbA1c levels of those who came for routine diabetes control within six months will be recorded and the sleep hygiene education compliance scale will be applied to the case group. Differences between groups will be evaluated using chi-square and Student's t tests. According to the results of the research, it will be tried to decide whether sleep hygiene education can be used in the treatment of type 2 diabetes patients.
Read the detailed description
Although there are many studies in the literature examining the relationship between diabetes mellitus and poor sleep quality, most of the studies are cross-sectional. While the relationship between sleep quality and blood glucose regulation was clearly shown in these studies, very few studies aimed to observe the effect of sleep quality correction on blood glucose regulation. As a result of this, of the 35 guidelines addressed in a meta-analysis conducted in 2020 only 14 guidelines included sleep in their recommendations, optimising sleep duration and quality and the management of sleep disorders were discussed as a therapeutic approach in 6 guidelines. In these also only 3 guidelines recommended optimal sleep duration as a therapeutic target of life style intervention and self-management education with one guideline identifying optimal sleep as a means of achieving glycaemic targets in T2DM .
In this randomised controlled study, it is aimed to provide evidence for the guidelines on the treatment of diabetes by demonstrating whether the education that includes simple lifestyle changes to increase sleep hygiene will have an effect on blood glucose regulation of Type 2 diabetes patients.
In the power analysis based on the tests to be used, when Type 1 error (α) = 0.05, Type 2 error (1-β) = 0.95, effect size is considered as 0.5; it was calculated that the sample size should be 210 (105 for each group) in total.
Patients with sleep disorders, language or psychiatric problems known to interfere with responding to the questionnaire, and patients whose antidiabetic treatment was changed at the first control examination will be excluded from the study.
In their first visit, the participants will be administered a routine diabetes control including HbA1c measurements, as well as a sociodemographic data collection questionnaire prepared by the researchers, a questionnaire consisting of 20 questions including questions about diabetes and sleep problems, and the Turkish version of the Pittsburgh Sleep Quality Index (PSQI) by face-to-face interview technique.
In addition, each patient included in the case group was given a brochure containing one-on-one sleep hygiene education and 10 lifestyle changes related to sleep hygiene, the content of which was created by the researchers.
Recommendations in the sleep hygiene leaflet :
- Enter the bed when you feel sleepy. If you lie in bed for more than half an hour, get out of bed. When you feel sleepy, go back to bed
- Do not sleep more than 1 hour during the day time.
- Avoid heavy and fatty meals in the evening, do not go to bed very hungry or very satiated. Avoid beverages such as coffee, tea, coke, energy drinks and alcohol.
- Exercise or walk regularly in the evening, but avoid physically strenuous activities 3-4 hours before bedtime
- In order for your body clock to work properly, live regularly. Get out of bed at the same time everyday. Wake up at the time you should wakeup in the morning, even if you went to bed at a different time of the night. Follow this rule, even on the weekend, and make it a habit to always get up at the same time. Sleeping and awakening times are important in maintaining sleep patterns.
- Use the bed for sleep purposes only. Do not do activities such as eating, watching TV, reading a book, or planning the next day in bed.
- Make sure your bedroom is quiet and dark
- Avoid exciting activities such as watching horror movies or reading adventure boks before going to bed
- Try to avoid a stressful life.
- Never take sleeping pills without your doctor's knowledge.
At the next visit of all participants, a second visit PSQI will be administered in addition to HbA1c, and a statement-based "sleep hygiene education compliance questionnaire" will be administered to the case group, questioning whether they have complied with the items in the sleep hygiene education material recommended at the first interview.
- Conditions
- Diabetes Mellitus, Type 2, Sleep Hygiene
- Being tested
- Sleep Hygiene
- Keywords
- Diabetes Mellitus Type 2, Sleep Hygiene, Treatment
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep HygieneBehavioural
- One-to-one sleep hygiene training, the content of which was created by the researchers,
- A brochure containing 10 lifestyle changes related to sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | Patients in the case group were given one-to-one sleep hygiene training by researchers and, a brochure containing 10 lifestyle changes related to sleep hygiene as well as they assessed at the first interview and the last interview, received routine health care, and Receives: Behavioral: Sleep Hygiene |
| Control group | No intervention | Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pıttsburgh Sleep Quality Index Score
Pıttsburgh sleep quality index score was used in order to determine whether the training provided increases the sleep quality or not.An increase in the second measured index score compared to the first measured Pitssburg sleep quality index score will indicate a decrease in sleep quality.
Measured: Within 3-6 months after first visit
Hba1c mmol/mol
To detect change in blood sugar regulation HbA1c values will be used. A decrease in the second measured HbA1c values compared to the first measured HbA1c values will indicate a positive effect on blood sugar regulation .
Measured: Within 3-6 months after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Jan 2018
- Primary completion1 Apr 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Süleyman Görpelioğlu, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Süleyman Görpelioğlu, Prof.Dr., Principal investigator, Academic staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918004
- Sponsor's protocol ID
- 27.11.2017 - 43/06
- Status last verified
- Jun 2021
- First submitted
- 30 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kachi Y, Nakao M, Takeuchi T, Yano E. Association between insomnia symptoms and hemoglobin A1c level in Japanese men. PLoS One. 2011;6(7):e21420. doi: 10.1371/journal.pone.0021420. Epub 2011 Jul 1.
PubMed 21747936Tan X, van Egmond L, Chapman CD, Cedernaes J, Benedict C. Aiding sleep in type 2 diabetes: therapeutic considerations. Lancet Diabetes Endocrinol. 2018 Jan;6(1):60-68. doi: 10.1016/S2213-8587(17)30233-4. Epub 2017 Aug 24.
PubMed 28844889Nedeltcheva AV, Scheer FA. Metabolic effects of sleep disruption, links to obesity and diabetes. Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):293-8. doi: 10.1097/MED.0000000000000082.
PubMed 24937041Spiegel K, Tasali E, Leproult R, Van Cauter E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat Rev Endocrinol. 2009 May;5(5):253-61. doi: 10.1038/nrendo.2009.23.
PubMed 19444258Lee SWH, Ng KY, Chin WK. The impact of sleep amount and sleep quality on glycemic control in type 2 diabetes: A systematic review and meta-analysis. Sleep Med Rev. 2017 Feb;31:91-101. doi: 10.1016/j.smrv.2016.02.001. Epub 2016 Feb 9.
PubMed 26944909Smyth A, Jenkins M, Dunham M, Kutzer Y, Taheri S, Whitehead L. Systematic review of clinical practice guidelines to identify recommendations for sleep in type 2 diabetes mellitus management. Diabetes Res Clin Pract. 2020 Dec;170:108532. doi: 10.1016/j.diabres.2020.108532. Epub 2020 Nov 4.
PubMed 33157114Zhu B, Hershberger PE, Kapella MC, Fritschi C. The relationship between sleep disturbance and glycaemic control in adults with type 2 diabetes: An integrative review. J Clin Nurs. 2017 Dec;26(23-24):4053-4064. doi: 10.1111/jocn.13899. Epub 2017 Jul 17.
PubMed 28544107Chasens ER, Korytkowski M, Sereika SM, Burke LE. Effect of poor sleep quality and excessive daytime sleepiness on factors associated with diabetes self-management. Diabetes Educ. 2013 Jan-Feb;39(1):74-82. doi: 10.1177/0145721712467683. Epub 2012 Nov 27.
PubMed 23192600Seibert PS, Valerio J, DeHaas C. The concomitant relationship shared by sleep disturbances and type 2 diabetes: developing telemedicine as a viable treatment option. J Diabetes Sci Technol. 2013 Nov 1;7(6):1607-15. doi: 10.1177/193229681300700621.
PubMed 24351187Larcher S, Benhamou PY, Pepin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23.
PubMed 25623152
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep hygıene traınıng gıven to patıents wıth dıabetes mellıtus on Blood Sugar regulatıon: a randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT04918004
- Acronym / sponsor ID
- 27.11.2017 - 43/06
- Conditions
- Diabetes Mellitus, Type 2, Sleep Hygiene
- Keywords
- Diabetes Mellitus Type 2, Sleep Hygiene, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 8 Jun 2021 (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.
Although many studies have shown an inverse relationship between blood glucose regulation and sleep hygiene, recommendations for improving sleep hygiene have not yet been included in diabetes treatment guidelines. In this study, it was aimed to reveal with a randomized controlled study whether training on sleep hygiene will have an effect on blood glucose regulation of Type 2 diabetes patients. Case and control groups will be formed by random sampling method. Pıttsburgh sleep quality index will be applied face to face and HbA1c values will be recorded for all patients included in the study. In addition, sleep hygiene training will be given to the case group. Among the patients included in the study, the second HbA1c levels of those who came for routine diabetes control within six months will be recorded and the sleep hygiene education compliance scale will be applied to the case group. Differences between groups will be evaluated using chi-square and Student's t tests. According to the results of the research, it will be tried to decide whether sleep hygiene education can be used in the treatment of type 2 diabetes patients.
Detailed description
Although there are many studies in the literature examining the relationship between diabetes mellitus and poor sleep quality, most of the studies are cross-sectional. While the relationship between sleep quality and blood glucose regulation was clearly shown in these studies, very few studies aimed to observe the effect of sleep quality correction on blood glucose regulation. As a result of this, of the 35 guidelines addressed in a meta-analysis conducted in 2020 only 14 guidelines included sleep in their recommendations, optimising sleep duration and quality and the management of sleep disorders were discussed as a therapeutic approach in 6 guidelines. In these also only 3 guidelines recommended optimal sleep duration as a therapeutic target of life style intervention and self-management education with one guideline identifying optimal sleep as a means of achieving glycaemic targets in T2DM .
In this randomised controlled study, it is aimed to provide evidence for the guidelines on the treatment of diabetes by demonstrating whether the education that includes simple lifestyle changes to increase sleep hygiene will have an effect on blood glucose regulation of Type 2 diabetes patients.
In the power analysis based on the tests to be used, when Type 1 error (α) = 0.05, Type 2 error (1-β) = 0.95, effect size is considered as 0.5; it was calculated that the sample size should be 210 (105 for each group) in total.
Patients with sleep disorders, language or psychiatric problems known to interfere with responding to the questionnaire, and patients whose antidiabetic treatment was changed at the first control examination will be excluded from the study.
In their first visit, the participants will be administered a routine diabetes control including HbA1c measurements, as well as a sociodemographic data collection questionnaire prepared by the researchers, a questionnaire consisting of 20 questions including questions about diabetes and sleep problems, and the Turkish version of the Pittsburgh Sleep Quality Index (PSQI) by face-to-face interview technique.
In addition, each patient included in the case group was given a brochure containing one-on-one sleep hygiene education and 10 lifestyle changes related to sleep hygiene, the content of which was created by the researchers.
Recommendations in the sleep hygiene leaflet :
- Enter the bed when you feel sleepy. If you lie in bed for more than half an hour, get out of bed. When you feel sleepy, go back to bed
- Do not sleep more than 1 hour during the day time.
- Avoid heavy and fatty meals in the evening, do not go to bed very hungry or very satiated. Avoid beverages such as coffee, tea, coke, energy drinks and alcohol.
- Exercise or walk regularly in the evening, but avoid physically strenuous activities 3-4 hours before bedtime
- In order for your body clock to work properly, live regularly. Get out of bed at the same time everyday. Wake up at the time you should wakeup in the morning, even if you went to bed at a different time of the night. Follow this rule, even on the weekend, and make it a habit to always get up at the same time. Sleeping and awakening times are important in maintaining sleep patterns.
- Use the bed for sleep purposes only. Do not do activities such as eating, watching TV, reading a book, or planning the next day in bed.
- Make sure your bedroom is quiet and dark
- Avoid exciting activities such as watching horror movies or reading adventure boks before going to bed
- Try to avoid a stressful life.
- Never take sleeping pills without your doctor's knowledge.
At the next visit of all participants, a second visit PSQI will be administered in addition to HbA1c, and a statement-based "sleep hygiene education compliance questionnaire" will be administered to the case group, questioning whether they have complied with the items in the sleep hygiene education material recommended at the first interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Behavioral: Sleep HygienePatients in the case group were given one-to-one sleep hygiene training by researchers and, a brochure containing 10 lifestyle changes related to sleep hygiene as well as they assessed at the first interview and the last interview, received routine health care, and |
| Control group | No intervention | –Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were admitted to our clinic with the diagnosis of diabetes mellitus type 2 during the study
Key exclusion criteria (5 listed)
- Patients with a known sleep disorder,
- Language or psychiatric problems that prevented responding to the questionnaire
- Patients who underwent changes in their antidiabetic treatment during the first control examination
- Those who did not re-admit to the hospital for routine check-ups within 6 months after the first visit
- Patients who declared not to comply with the recommendations were excluded from the study
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 |
|---|---|---|
| Sleep Hygiene1. One-to-one sleep hygiene training, the content of which was created by the researchers, 2. A brochure containing 10 lifestyle changes related to sleep hygiene | Behavioural | Case group |
Primary outcome
Pıttsburgh Sleep Quality Index Score
Time frame: Within 3-6 months after first visit
Pıttsburgh sleep quality index score was used in order to determine whether the training provided increases the sleep quality or not.An increase in the second measured index score compared to the first measured Pitssburg sleep quality index score will indicate a decrease in sleep quality.
Hba1c mmol/mol
Time frame: Within 3-6 months after first visit
To detect change in blood sugar regulation HbA1c values will be used. A decrease in the second measured HbA1c values compared to the first measured HbA1c values will indicate a positive effect on blood sugar regulation .
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 10 Jun 2021.
- Background: PubMed 21747936Kachi Y, Nakao M, Takeuchi T, Yano E. Association between insomnia symptoms and hemoglobin A1c level in Japanese men. PLoS One. 2011;6(7):e21420. doi: 10.1371/journal.pone.0021420. Epub 2011 Jul 1.
- Background: PubMed 28844889Tan X, van Egmond L, Chapman CD, Cedernaes J, Benedict C. Aiding sleep in type 2 diabetes: therapeutic considerations. Lancet Diabetes Endocrinol. 2018 Jan;6(1):60-68. doi: 10.1016/S2213-8587(17)30233-4. Epub 2017 Aug 24.
- Background: PubMed 24937041Nedeltcheva AV, Scheer FA. Metabolic effects of sleep disruption, links to obesity and diabetes. Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):293-8. doi: 10.1097/MED.0000000000000082.
- Background: PubMed 19444258Spiegel K, Tasali E, Leproult R, Van Cauter E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat Rev Endocrinol. 2009 May;5(5):253-61. doi: 10.1038/nrendo.2009.23.
- Background: PubMed 26944909Lee SWH, Ng KY, Chin WK. The impact of sleep amount and sleep quality on glycemic control in type 2 diabetes: A systematic review and meta-analysis. Sleep Med Rev. 2017 Feb;31:91-101. doi: 10.1016/j.smrv.2016.02.001. Epub 2016 Feb 9.
- Background: PubMed 33157114Smyth A, Jenkins M, Dunham M, Kutzer Y, Taheri S, Whitehead L. Systematic review of clinical practice guidelines to identify recommendations for sleep in type 2 diabetes mellitus management. Diabetes Res Clin Pract. 2020 Dec;170:108532. doi: 10.1016/j.diabres.2020.108532. Epub 2020 Nov 4.
- Background: PubMed 28544107Zhu B, Hershberger PE, Kapella MC, Fritschi C. The relationship between sleep disturbance and glycaemic control in adults with type 2 diabetes: An integrative review. J Clin Nurs. 2017 Dec;26(23-24):4053-4064. doi: 10.1111/jocn.13899. Epub 2017 Jul 17.
- Background: PubMed 23192600Chasens ER, Korytkowski M, Sereika SM, Burke LE. Effect of poor sleep quality and excessive daytime sleepiness on factors associated with diabetes self-management. Diabetes Educ. 2013 Jan-Feb;39(1):74-82. doi: 10.1177/0145721712467683. Epub 2012 Nov 27.
- Background: PubMed 24351187Seibert PS, Valerio J, DeHaas C. The concomitant relationship shared by sleep disturbances and type 2 diabetes: developing telemedicine as a viable treatment option. J Diabetes Sci Technol. 2013 Nov 1;7(6):1607-15. doi: 10.1177/193229681300700621.
- Background: PubMed 25623152Larcher S, Benhamou PY, Pepin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23.
- TEMD Diabetes Mellitus Çalışma ve Eğitim Grubu, Diagnosis and Monitoring Guide for Diabetes Mellitus and Its Complications 2020 Türkiye Endokrinoloji ve Metabolizma Derneği: 2020. p.40-44Link provided by the sponsor.
- Agargün M Y, Kara H, Anlar O (1996) Validity and Reliability of Pittsburgh Sleep Quality. Türk Psikiyatri Dergisi, 7: 107-115.Link provided by the sponsor.
- TurcosaAnalytics (2021). TURCOSA \[Cloud-based statistical software\].Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Süleyman Görpelioğlu, Prof.Dr. principal investigator
Academic staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene in people with Diabetes Mellitus, Type 2 and Sleep Hygiene, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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 10 Jun 2021. 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 Turkey (Türkiye). 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?
Pıttsburgh Sleep Quality Index Score (time frame: Within 3-6 months after first visit). The study lists 2 primary outcomes in all. 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 NCT04918004, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.