Poor Quality SleepNCT06556303
Acupressure and Sleep Quality of Nursing Students
A study testing Acupressure in people with Poor Quality Sleep, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This randomised, controlled and experimental study was conducted between 15 April and 15 June 2022 to examine the effect of acupressure on sleep quality of fourth-year nursing students. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Jun 2022
- 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 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study included fourth-year nursing students of the relevant faculty, who had a PSQI score of five or above, had no comorbidities (heart disease, migraine, psychiatric comorbidities, etc.), were not on medication for sleep problems, and volunteered to participate in the study
Who cannot join
- The students who failed to meet the inclusion criteria were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Unıversty
Gaziantep, Sehitkamil, 27000
About this study
Official title: THE EFFECT OF ACUPRESSURE ON SLEEP QUALITY OF NURSING STUDENTS: A Randomised Controlled Study
This randomised, controlled and experimental study was conducted between 15 April and 15 June 2022 to examine the effect of acupressure on sleep quality of fourth-year nursing students. The population of the study consisted of all fourth-year nursing students and the sample consisted of 53 students who met the inclusion criteria. Approval from the ethics committee, permission from the institution and consents from the students were obtained before the research. The participants were assigned to intervention (n=26) and control (n=27) groups by simple random sampling method. The students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. A questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were applied at the beginning of the study, and the PSQI was applied again at the end of the fourth week. Total score of the PSQI ranges from 0 to 21. A total score higher than five indicates poor sleep quality. It was found that the PSQI total mean score of the intervention group dropped from 8.53±2.45 to 6.38±3.64, while the PSQI total mean score of the control group decreased from 9.40±1.62 to 8.40±3.48 (p<0.05). Also, subjective sleep quality, sleep disturbances and daytime dysfunction significantly decreased in the intervention group (p<0.05).
Read the detailed description
Sleep is a brain function and is crucial for the maintenance of physical and mental health. Sleep, during which we spend approximately one-third of the life, is also a multidimensional and active state1. Therefore, it has been pointed out that sleep is a priority requirement in terms of protection and maintenance of health and quality of life2. In the literature, it is reported that the prevalence of sleep disorder is 5% in the world and 21.8% in Turkey, sleep-related complaints are frequently experienced, and poor sleep leads to physical and psychological disorders3. Quality sleep is described as a person who feels energetic and ready for a new day after waking up. Sleep quality includes quantitative aspects of sleep such as sleep latency, sleep duration and the number of wake-ups in a night, as well as subjective aspects such as the depth and restfulness of sleep. However, working conditions, occupational factors and stress can significantly affect the structure and quality of sleep. Sleeping disorders are observed more frequently, especially in patients with chronic diseases, healthcare personnel and people who work on call. The on-call working system of healthcare professionals disrupts the natural rhythm of human physiology and the sleep-wake cycle4. Studies have shown that the on-call system disrupts the natural circadian rhythm and may lead to serious changes in the gastrointestinal, cardiovascular and metabolic systems as well as the family and social life of nurses1. As known, the nursing profession, providing uninterrupted health care, requires working in shifts and may predispose to the appearance of sleeping disorders in this profession5. Also, an intensive and practical education programme is implemented during nursing education in Turkey and this may cause students to suffer from problems such as sleep deprivation, loss of performance and concentration6. A study conducted with nursing students found that students suffer from sleep problems more frequently compared to the general population and this causes physical problems and accidents as well as psychosocial problems such as low academic success, substance withdrawal, substance addiction, and emotional-behavioural and eating disorders7. However, it is very important that nursing students, who will deliver health services to society following their education, should have a complete physical and mental well-being and be able to maintain this state6. Accordingly, it is significant that students who are educated in health disciplines, all of whose practices are related to human health and therefore require an open mind and attention, acquire healthy lifestyle habits. Therefore, it is recommended to identify the present condition to ensure adequate and quality sleep, one of the parameters of a healthy lifestyle, and to use some supportive methods for enhancing the quality of sleep7. Today, pharmacological and non-pharmacological approaches are generally utilised to manage sleep disorders. However, non-pharmacological approaches may be preferred more due to their fewer side effects8. Acupressure, one of these methods, is stressed to be a reliable and effective practice that positively affects sleep by releasing neural mediators in order to enhance sleep quality9. Many studies have also found that acupressure practice has positive effects on sleep quality.10,11 Başer et al., found that acupressure applied on Tian-Zhu, Ju-Que, YongQuan, Bai-Hui and Nei-Guan points for 24 minutes three times a week for eight weeks in the elderly improved sleep quality.8,12 Similarly, it was found that acupressure applied on Neiguan (PC6), Shen Men (HT7), Sanyinjiao (SP6), Yintang (EX-HN3) and Tay (EX5) points for two minutes and once a day for two days improved sleep quality in patients who were followed for acute myocardial infarction.13 This information clearly suggests that acupressure contributes positively to sleep quality. Therefore, this study aimed to assess the effect of acupressure applied to the fourth-year nursing students who attended their practical education in clinics on sleep quality.
MATERIALS AND METHODS This randomised, controlled and experimental study was conducted between 15 April and 15 June 2022 to evaluate the effect of acupressure on fourth-year nursing students on sleep quality. The population of the study consisted of all fourth-year nursing students who continued their clinical practice education, and the sample consisted of 53 students with a PSQI score of five and above. The minimum sample size required in both groups to find the difference of 4.50 units (Cohen's d=1.45) between two mean scores between the acupressure group and the non-acupressure group in terms of Pittsburgh Sleep Quality Index (PSQI) scores to be significant was calculated as 12 (α=0.05, 1-β=0.90) (12). Students were assigned to intervention and control groups by using a computer programme for randomisation. The study included fourth-year nursing students of the relevant faculty, who had a PSQI score of five or above, had no comorbidities (heart disease, migraine, psychiatric comorbidities, etc.), were not on medication for sleep problems, and volunteered to participate in the study.14 The students who failed to meet the inclusion criteria were excluded from the study.
Acupressure Acupressure was applied on Shenmen (HT7)9,11 (Image 1),15 located at the tip of the ulnar bone and the heart meridian, Sanyinjiao (SP6) (Image 2),16 the sixth point of the splenic meridian approximately four fingers above the ankle, Neiguan (PC6) (Image 3),17 a pericardium point located between two tendons three fingers above the wrist in the forearm, and Tian-Zhu (BL10) (Image 4)18 acupuncture points on the neck of the students in the intervention group for two minutes on each point, on the right and left, for a total of 16 minutes, three days a week for four weeks. In both intervention and control groups, a questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were applied at the beginning of the study, and the PSQI was applied again at the end of the fourth week.13 Acupressure was applied by the researcher having a certificate on the examination couch in a room prepared for the application by scheduling an appointment for each student. The student was placed in the Fowler position for the acupressure on Shenmen (HT7), Sanyinjiao (SP6) and Neiguan (PC6) points and in the supine position for the acupressure on Tian-Zhu (BL10) point. Any application was not practised in the control group. However, one session of acupressure was applied at the end of the study.
- Conditions
- Poor Quality Sleep
- Being tested
- Acupressure
- Keywords
- Nursing students, Acupressure, Sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Some Characteristics of the Students with Sleep Quality Mean Score | Experimental | The students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. Receives: Other: Acupressure |
| Students and Their Sleep Quality Mean Score Before Acupressure Application | Experimental | The students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. Receives: Other: Acupressure |
| Comparison of Sleep Quality Total Scores and Subscale Mean Scores of Intervention and Control Groups | Experimental | The students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. Receives: Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep during the Follow-up
This scale consists of seven subscales (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunctions) and 19 items. The sum of all subscales is assessed with a total sleep quality score ranging from 0 to 21. A total score higher than five indicates poor sleep quality
Measured: one mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies 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 controlled experimental study model
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Serce, University of Gaziantep
- Investigators
- Sibel Serçe, Asst. Prof., Principal investigator, Gaziantep UniverstyOzlem Ovayolu, Prof, Study chair, Gaziantep UniverstyNimet Ovayolu, Prof, Study chair, SANKO Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556303
- Sponsor's protocol ID
- 13082024
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ACUPRESSURE ON SLEEP QUALITY OF NURSING STUDENTS: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06556303
- Acronym / sponsor ID
- 13082024
- Conditions
- Poor Quality Sleep
- Keywords
- Nursing students, Acupressure, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Aug 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.
This randomised, controlled and experimental study was conducted between 15 April and 15 June 2022 to examine the effect of acupressure on sleep quality of fourth-year nursing students. The population of the study consisted of all fourth-year nursing students and the sample consisted of 53 students who met the inclusion criteria. Approval from the ethics committee, permission from the institution and consents from the students were obtained before the research. The participants were assigned to intervention (n=26) and control (n=27) groups by simple random sampling method. The students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. A questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were applied at the beginning of the study, and the PSQI was applied again at the end of the fourth week. Total score of the PSQI ranges from 0 to 21. A total score higher than five indicates poor sleep quality. It was found that the PSQI total mean score of the intervention group dropped from 8.53±2.45 to 6.38±3.64, while the PSQI total mean score of the control group decreased from 9.40±1.62 to 8.40±3.48 (p<0.05). Also, subjective sleep quality, sleep disturbances and daytime dysfunction significantly decreased in the intervention group (p<0.05).
Detailed description
Sleep is a brain function and is crucial for the maintenance of physical and mental health. Sleep, during which we spend approximately one-third of the life, is also a multidimensional and active state1. Therefore, it has been pointed out that sleep is a priority requirement in terms of protection and maintenance of health and quality of life2. In the literature, it is reported that the prevalence of sleep disorder is 5% in the world and 21.8% in Turkey, sleep-related complaints are frequently experienced, and poor sleep leads to physical and psychological disorders3. Quality sleep is described as a person who feels energetic and ready for a new day after waking up. Sleep quality includes quantitative aspects of sleep such as sleep latency, sleep duration and the number of wake-ups in a night, as well as subjective aspects such as the depth and restfulness of sleep. However, working conditions, occupational factors and stress can significantly affect the structure and quality of sleep. Sleeping disorders are observed more frequently, especially in patients with chronic diseases, healthcare personnel and people who work on call. The on-call working system of healthcare professionals disrupts the natural rhythm of human physiology and the sleep-wake cycle4. Studies have shown that the on-call system disrupts the natural circadian rhythm and may lead to serious changes in the gastrointestinal, cardiovascular and metabolic systems as well as the family and social life of nurses1. As known, the nursing profession, providing uninterrupted health care, requires working in shifts and may predispose to the appearance of sleeping disorders in this profession5. Also, an intensive and practical education programme is implemented during nursing education in Turkey and this may cause students to suffer from problems such as sleep deprivation, loss of performance and concentration6. A study conducted with nursing students found that students suffer from sleep problems more frequently compared to the general population and this causes physical problems and accidents as well as psychosocial problems such as low academic success, substance withdrawal, substance addiction, and emotional-behavioural and eating disorders7. However, it is very important that nursing students, who will deliver health services to society following their education, should have a complete physical and mental well-being and be able to maintain this state6. Accordingly, it is significant that students who are educated in health disciplines, all of whose practices are related to human health and therefore require an open mind and attention, acquire healthy lifestyle habits. Therefore, it is recommended to identify the present condition to ensure adequate and quality sleep, one of the parameters of a healthy lifestyle, and to use some supportive methods for enhancing the quality of sleep7. Today, pharmacological and non-pharmacological approaches are generally utilised to manage sleep disorders. However, non-pharmacological approaches may be preferred more due to their fewer side effects8. Acupressure, one of these methods, is stressed to be a reliable and effective practice that positively affects sleep by releasing neural mediators in order to enhance sleep quality9. Many studies have also found that acupressure practice has positive effects on sleep quality.10,11 Başer et al., found that acupressure applied on Tian-Zhu, Ju-Que, YongQuan, Bai-Hui and Nei-Guan points for 24 minutes three times a week for eight weeks in the elderly improved sleep quality.8,12 Similarly, it was found that acupressure applied on Neiguan (PC6), Shen Men (HT7), Sanyinjiao (SP6), Yintang (EX-HN3) and Tay (EX5) points for two minutes and once a day for two days improved sleep quality in patients who were followed for acute myocardial infarction.13 This information clearly suggests that acupressure contributes positively to sleep quality. Therefore, this study aimed to assess the effect of acupressure applied to the fourth-year nursing students who attended their practical education in clinics on sleep quality.
MATERIALS AND METHODS This randomised, controlled and experimental study was conducted between 15 April and 15 June 2022 to evaluate the effect of acupressure on fourth-year nursing students on sleep quality. The population of the study consisted of all fourth-year nursing students who continued their clinical practice education, and the sample consisted of 53 students with a PSQI score of five and above. The minimum sample size required in both groups to find the difference of 4.50 units (Cohen's d=1.45) between two mean scores between the acupressure group and the non-acupressure group in terms of Pittsburgh Sleep Quality Index (PSQI) scores to be significant was calculated as 12 (α=0.05, 1-β=0.90) (12). Students were assigned to intervention and control groups by using a computer programme for randomisation. The study included fourth-year nursing students of the relevant faculty, who had a PSQI score of five or above, had no comorbidities (heart disease, migraine, psychiatric comorbidities, etc.), were not on medication for sleep problems, and volunteered to participate in the study.14 The students who failed to meet the inclusion criteria were excluded from the study.
Acupressure Acupressure was applied on Shenmen (HT7)9,11 (Image 1),15 located at the tip of the ulnar bone and the heart meridian, Sanyinjiao (SP6) (Image 2),16 the sixth point of the splenic meridian approximately four fingers above the ankle, Neiguan (PC6) (Image 3),17 a pericardium point located between two tendons three fingers above the wrist in the forearm, and Tian-Zhu (BL10) (Image 4)18 acupuncture points on the neck of the students in the intervention group for two minutes on each point, on the right and left, for a total of 16 minutes, three days a week for four weeks. In both intervention and control groups, a questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were applied at the beginning of the study, and the PSQI was applied again at the end of the fourth week.13 Acupressure was applied by the researcher having a certificate on the examination couch in a room prepared for the application by scheduling an appointment for each student. The student was placed in the Fowler position for the acupressure on Shenmen (HT7), Sanyinjiao (SP6) and Neiguan (PC6) points and in the supine position for the acupressure on Tian-Zhu (BL10) point. Any application was not practised in the control group. However, one session of acupressure was applied at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled experimental study model
| Arm | Type | Receives |
|---|---|---|
| Comparison of Some Characteristics of the Students with Sleep Quality Mean Score | Experimental | Other: AcupressureThe students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. |
| Students and Their Sleep Quality Mean Score Before Acupressure Application | Experimental | Other: AcupressureThe students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. |
| Comparison of Sleep Quality Total Scores and Subscale Mean Scores of Intervention and Control Groups | Experimental | Other: AcupressureThe students in the intervention group were subjected to acupressure on the right and left sides of Shenmen (HT7) acupuncture point of the heart meridian, Sanyinjiao (SP6) acupuncture point of the spleen meridian, Neiguan (PC6) acupuncture point of the pericardium point, and Tian-Zhu (BL10) acupuncture point of the neck. The researcher having the certificate practised acupressure on each point for two minutes each, totalling 16 minutes, three days a week for four weeks. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study included fourth-year nursing students of the relevant faculty, who had a PSQI score of five or above, had no comorbidities (heart disease, migraine, psychiatric comorbidities, etc.), were not on medication for sleep problems, and volunteered to participate in the study
Key exclusion criteria (1 listed)
- The students who failed to meet the inclusion criteria 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 |
|---|---|---|
| AcupressureAcupressure | Other | Comparison of Sleep Quality Total Scores and Subscale Mean Scores of Intervention and Control Groups, Comparison of Some Characteristics of the Students with Sleep Quality Mean Score, Students and Their Sleep Quality Mean Score Before Acupressure Application |
Primary outcome
Change in sleep during the Follow-up
Time frame: one mounth
This scale consists of seven subscales (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunctions) and 19 items. The sum of all subscales is assessed with a total sleep quality score ranging from 0 to 21. A total score higher than five indicates poor sleep quality
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 16 Aug 2024.
- 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.
Sibel Serçe, Asst. Prof. principal investigator
Gaziantep Universty
Ozlem Ovayolu, Prof study chair
Gaziantep Universty
Nimet Ovayolu, Prof study chair
SANKO Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Poor Quality Sleep, run by University of Gaziantep 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 1 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 16 Aug 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 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?
Change in sleep during the Follow-up (time frame: one mounth). 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 16 Aug 2024.