SleepRESTNCT02982239
Recovery Enhancement and Sleep Training
A study testing Sleep Diary, Fitness tracker and Blue-Blocking Glasses in people with Sleep and Performance, run by University of Arizona.
Trial summary
Evidence suggests that student athletes frequently experience sleep problems and are aware of the impact of sleep loss on mental and physical outcomes. As such, student athletes are motivated to improve sleep quality in order to improve their outcomes for overall athletic performance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Performance, Mental Health
- What is being tested?
- Sleep Diary, Fitness tracker and Blue-Blocking Glasses
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 5 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate
- Participation as a student-athlete during the entirety of their season
- No medical conditions that would preclude them from participating (assessed by self-report)
- Age ≥18 years
Who cannot join
- Freshmen
About this study
Official title: Recovery Enhancement and Sleep Training (REST): Sleep and Mental Well-Being in Student Athletes
Evidence suggests that student athletes frequently experience sleep problems and are aware of the impact of sleep loss on mental and physical outcomes. As such, student athletes are motivated to improve sleep quality in order to improve their outcomes for overall athletic performance. This study will consist of two parts. The first part will be a survey. Fall athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a survey within the first week of their arrival on campus. The survey will assess multiple domains of student-athlete health, namely, sleep duration and quality, mood and depression, stress, and mental and physical well-being. The responses to the survey will be confidential, and students will be compensated for the survey. At the end of the semester, students will be invited to complete the survey again.
Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the intervention, based on predetermined criteria. The intervention will include an information session where students may ask questions. Students will be sent text message reminders about adherence to the program and will be asked to monitor their sleep quality with sleep diaries. The intervention will consist of the half of the 40 chosen students, (20 students), who will be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit bit. Please note that all of these items are commercially available and are not meant to be used to treat or prevent human illness nor injury and do not require FDA oversight. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as well as adherence to the program.
Read the detailed description
Student athletes face many challenges to their ability to maintain healthy mental and physical well-being. The college experience is associated with a number of physiologic, social, and environmental stressors that can exert long-term effects on an individual's future health and quality of life. In addition, unique demands of student-athletes, including academic, physical performance, scheduling, and travel demands, all represent additional stressors that interact to produce in poorer outcomes.
Insufficient sleep duration and poor sleep quality have been increasingly identified as important risk factors for physical and mental well-being, especially among young adults. For example, insufficient and/or poor quality sleep is strongly associated with the development of cardiometabolic disease risk factors, obesity, depression, anxiety disorders, alcohol use, other substance use, poorer academic performance, and reduced mental well-being, in addition to poorer athletic performance.
Data from a recent PAC12 conference report shows that 2/3 of students indicated that lack of flexible time is the hardest thing about being an athlete, more than academic work. Further, students identified sleep as the first thing that their athletic time commitments kept them from doing, 77% felt that they got less sleep than non-athletes, and >50% indicated that they would use an extra hour to catch up on sleep. In 2015 data from the American College Health Association, (1) 29% of student athletes report significant sleep difficulties, (2) 40% reported getting enough sleep on only ≤3 nights, (3) 10% reported no problems with daytime sleepiness, (4) >15% reported sleepiness to be at least "a big problem," (5) >25% reported extreme difficulty falling asleep ≥3 nights/week (consistent with a diagnosis of insomnia), and (6) >50% reported that sleep problems impacted academic performance. Thus, student-athletes frequently experience sleep problems, they recognize the impact of sleep loss, and they are likely motivated to improve sleep. These data are consistent with data from professional athletes, whose overall sleep quality is poorer than non-athletes.
Taken together, sleep is an aspect of health that is implicated in many of the most salient mental and physical outcomes among college athletes. Despite this, obtaining sufficient sleep represents one of the greatest challenges facing student athletes. No programmatic approaches have been able to address this problem.
Accordingly, the proposed study aims to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes. This intervention will be assessed with and without the assistance of tools to aid in tracking sleep and adjusting to difficult schedules in order to evaluate the utility of those approaches.
The purpose of this research study is to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes.
Overall objectives AIM 1: Assess cross-sectional relationships among sleep, circadian preference, and outcomes including overall mental health, stress, mood, anxiety, social functioning, and physical well-being.
AIM 2: Determine whether a simple sleep health intervention, with and without the aid of technology, is associated with improvements in mental and physical well-being.
Primary outcome variable(s) AIM 1: depression score, stress score, mental well-being score, anxiety score, and physical well-being score AIM 2: changes in AIM 1 outcomes Secondary outcome variable(s) Academic stress, physical performance, substance use, health behaviors, soft tissue injuries, missed practices, academic performance
- Conditions
- Sleep, Performance, Mental Health, Stress, Anxiety
- Being tested
- Sleep Diary, Fitness tracker, Blue-Blocking Glasses, LED light, Information Session
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DiaryBehavioural
All 40 chosen students will be provided a link to complete a daily sleep diary for 10 weeks. Sleep diary will assess activity before bed, bedtime, time to fall asleep, number of awakenings, time awake after sleep onset, time out of bed, time of final awakening, perceived sleep quality. Diary also asks about naps taken during the day, caffeine and tobacco consumption, and an additional space for open-ended comments from the participant.
Fitness trackerDevice
All 40 chosen students will receive a fitness tracker. The fit bit will estimate sleep and physical activity as well as adherence to the program. participants will have access to their own data. Data will also be monitored from the lab using Fitabase which provides access to day, hour, and minute-level resolution of data for steps taken, intensity class, calories burned, and sleep (length, movement, and quality).
Blue-Blocking GlassesDevice
Half of the 40 chosen students (N=20) will be provided with blue blocking glasses. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier.
LED lightDevice
Half of the 40 chosen students (N=20) will be provided with a bright LED light. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes.
Information SessionOther
Also called Educational session
all 40 participants will attend a 1-hour information session about sleep delivered by the PIs, to be followed by a 1-hour Q\&A period.
Peer educators will receive and extra 1-hour training session on how to handle questions and when to refer back to the PIs.
Text messagesBehavioural
All participants will receive text messages in the evening that will include adherence reminders, encouraging statements, and tips for improving sleep. Messages will be randomized, with no more than 3 messages of any type per week. Messages will serve as a cue to action without being overly repetitive or predictable.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Intervention | Other | N=20 Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks Receives: Behavioral: Sleep Diary; Device: Fitness tracker; Other: Information Session; Behavioral: Text messages |
| Sleep Intervention plus Tech | Other | N=20 Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks. Receives: Behavioral: Sleep Diary; Device: Fitness tracker; Device: Blue-Blocking Glasses; Device: LED light; Other: Information Session; Behavioral: Text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index ( PSQI)
Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.
Measured: Change from baseline to post-intervention, around 10 weeks after baseline
Insomnia Severity Index (ISI)
Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: Change from baseline to post intervention, around 10 weeks after baseline
Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.
Measured: Change from baseline to post intervention, around 10 weeks after baseline
Centers for Epidemiological Studies Depression Scale (CESD)
Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measured: Change from baseline to post intervention, around 10 weeks after baseline
Perceived Stress Scale (PSS)
Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress.
Measured: Change from baseline to post intervention, around 10 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJun 2016
- Primary completion4 Jan 2017
- Study completion5 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Collegiate Athletic Association - NCAA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982239
- Sponsor's protocol ID
- 1605615210
- Acronym
- REST
- Status last verified
- Nov 2016
- First submitted
- 25 Oct 2016
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Enhancement and Sleep Training (REST): Sleep and Mental Well-Being in Student Athletes
- ClinicalTrials.gov ID
- NCT02982239
- Acronym / sponsor ID
- REST / 1605615210
- Conditions
- Sleep, Performance, Mental Health, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Collegiate Athletic Association - NCAA
- Study start
- Jun 2016 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence suggests that student athletes frequently experience sleep problems and are aware of the impact of sleep loss on mental and physical outcomes. As such, student athletes are motivated to improve sleep quality in order to improve their outcomes for overall athletic performance. This study will consist of two parts. The first part will be a survey. Fall athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a survey within the first week of their arrival on campus. The survey will assess multiple domains of student-athlete health, namely, sleep duration and quality, mood and depression, stress, and mental and physical well-being. The responses to the survey will be confidential, and students will be compensated for the survey. At the end of the semester, students will be invited to complete the survey again.
Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the intervention, based on predetermined criteria. The intervention will include an information session where students may ask questions. Students will be sent text message reminders about adherence to the program and will be asked to monitor their sleep quality with sleep diaries. The intervention will consist of the half of the 40 chosen students, (20 students), who will be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit bit. Please note that all of these items are commercially available and are not meant to be used to treat or prevent human illness nor injury and do not require FDA oversight. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as well as adherence to the program.
Detailed description
Student athletes face many challenges to their ability to maintain healthy mental and physical well-being. The college experience is associated with a number of physiologic, social, and environmental stressors that can exert long-term effects on an individual's future health and quality of life. In addition, unique demands of student-athletes, including academic, physical performance, scheduling, and travel demands, all represent additional stressors that interact to produce in poorer outcomes.
Insufficient sleep duration and poor sleep quality have been increasingly identified as important risk factors for physical and mental well-being, especially among young adults. For example, insufficient and/or poor quality sleep is strongly associated with the development of cardiometabolic disease risk factors, obesity, depression, anxiety disorders, alcohol use, other substance use, poorer academic performance, and reduced mental well-being, in addition to poorer athletic performance.
Data from a recent PAC12 conference report shows that 2/3 of students indicated that lack of flexible time is the hardest thing about being an athlete, more than academic work. Further, students identified sleep as the first thing that their athletic time commitments kept them from doing, 77% felt that they got less sleep than non-athletes, and >50% indicated that they would use an extra hour to catch up on sleep. In 2015 data from the American College Health Association, (1) 29% of student athletes report significant sleep difficulties, (2) 40% reported getting enough sleep on only ≤3 nights, (3) 10% reported no problems with daytime sleepiness, (4) >15% reported sleepiness to be at least "a big problem," (5) >25% reported extreme difficulty falling asleep ≥3 nights/week (consistent with a diagnosis of insomnia), and (6) >50% reported that sleep problems impacted academic performance. Thus, student-athletes frequently experience sleep problems, they recognize the impact of sleep loss, and they are likely motivated to improve sleep. These data are consistent with data from professional athletes, whose overall sleep quality is poorer than non-athletes.
Taken together, sleep is an aspect of health that is implicated in many of the most salient mental and physical outcomes among college athletes. Despite this, obtaining sufficient sleep represents one of the greatest challenges facing student athletes. No programmatic approaches have been able to address this problem.
Accordingly, the proposed study aims to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes. This intervention will be assessed with and without the assistance of tools to aid in tracking sleep and adjusting to difficult schedules in order to evaluate the utility of those approaches.
The purpose of this research study is to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes.
Overall objectives AIM 1: Assess cross-sectional relationships among sleep, circadian preference, and outcomes including overall mental health, stress, mood, anxiety, social functioning, and physical well-being.
AIM 2: Determine whether a simple sleep health intervention, with and without the aid of technology, is associated with improvements in mental and physical well-being.
Primary outcome variable(s) AIM 1: depression score, stress score, mental well-being score, anxiety score, and physical well-being score AIM 2: changes in AIM 1 outcomes Secondary outcome variable(s) Academic stress, physical performance, substance use, health behaviors, soft tissue injuries, missed practices, academic performance
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Intervention | Other | Behavioral: Sleep Diary, Device: Fitness tracker, Other: Information Session, Behavioral: Text messagesN=20 Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks |
| Sleep Intervention plus Tech | Other | Behavioral: Sleep Diary, Device: Fitness tracker, Device: Blue-Blocking Glasses, Device: LED light, Other: Information Session, Behavioral: Text messagesN=20 Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness to participate
- Participation as a student-athlete during the entirety of their season
- No medical conditions that would preclude them from participating (assessed by self-report)
- Age ≥18 years
Key exclusion criteria (1 listed)
- Freshmen
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 DiaryAll 40 chosen students will be provided a link to complete a daily sleep diary for 10 weeks. Sleep diary will assess activity before bed, bedtime, time to fall asleep, number of awakenings, time awake after sleep onset, time out of bed, time of final awakening, perceived sleep quality. Diary also asks about naps taken during the day, caffeine and tobacco consumption, and an additional space for open-ended comments from the participant. | Behavioural | Sleep Intervention, Sleep Intervention plus Tech |
| Fitness trackerAll 40 chosen students will receive a fitness tracker. The fit bit will estimate sleep and physical activity as well as adherence to the program. participants will have access to their own data. Data will also be monitored from the lab using Fitabase which provides access to day, hour, and minute-level resolution of data for steps taken, intensity class, calories burned, and sleep (length, movement, and quality). | Device | Sleep Intervention, Sleep Intervention plus Tech |
| Blue-Blocking GlassesHalf of the 40 chosen students (N=20) will be provided with blue blocking glasses. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier. | Device | Sleep Intervention plus Tech |
| LED lightHalf of the 40 chosen students (N=20) will be provided with a bright LED light. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes. | Device | Sleep Intervention plus Tech |
| Information SessionAlso: Educational sessionall 40 participants will attend a 1-hour information session about sleep delivered by the PIs, to be followed by a 1-hour Q\&A period. Peer educators will receive and extra 1-hour training session on how to handle questions and when to refer back to the PIs. | Other | Sleep Intervention, Sleep Intervention plus Tech |
| Text messagesAll participants will receive text messages in the evening that will include adherence reminders, encouraging statements, and tips for improving sleep. Messages will be randomized, with no more than 3 messages of any type per week. Messages will serve as a cue to action without being overly repetitive or predictable. | Behavioural | Sleep Intervention, Sleep Intervention plus Tech |
Primary outcome
Pittsburgh Sleep Quality Index ( PSQI)
Time frame: Change from baseline to post-intervention, around 10 weeks after baseline
Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.
Insomnia Severity Index (ISI)
Time frame: Change from baseline to post intervention, around 10 weeks after baseline
Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
Time frame: Change from baseline to post intervention, around 10 weeks after baseline
Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.
Centers for Epidemiological Studies Depression Scale (CESD)
Time frame: Change from baseline to post intervention, around 10 weeks after baseline
Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Perceived Stress Scale (PSS)
Time frame: Change from baseline to post intervention, around 10 weeks after baseline
Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Diary, Fitness tracker and Blue-Blocking Glasses in people with Sleep and Performance, run by University of Arizona.
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 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pittsburgh Sleep Quality Index ( PSQI) (time frame: Change from baseline to post-intervention, around 10 weeks after baseline). The study lists 5 primary outcomes in all. 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 19 Jul 2019.