Poor Quality SleepNCT04316663
Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality
A study testing Well-Being Intervention and Sleep Hygiene in people with Poor Quality Sleep, run by Columbia University at 1 site in United States.
Trial summary
The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- Well-Being Intervention and Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 20 Apr 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Distress according to the Perceived Stress Scale
- Poor sleep quality according to the Pittsburgh Sleep Quality Index
- No diagnosis of sleep disorders
- English fluency
- Access to a computer with an Internet connection
Who cannot join
- Inability to provide informed consent for any reason
- Cognitive impairment according to the Montreal Cognitive Assessment
- Suspected presence of sleep apnea according to the Berlin Questionnaire
- Diagnosis of a chronic medical or psychiatric condition
- Severe depression or suicidal thoughts or wishes according to the Beck Depression Inventory
- Body Mass Index (BMI) ≥ 35 kg/m2
Show all 16Show fewer
- Chronic use of medications for sleep or chronic medical and psychiatric conditions
- Any current psychological or behavioral intervention administered by a health care provider or as part of a research project
- Shift workers
- Pregnant women
- Parents or caregivers of newborns (<1 year)
- Heavy drinkers (≥ 8 drinks/week for women and ≥ 15 drinks/week for men)
- Binge drinkers (≥ 4 drinks on a single occasion within about 2 hours for women and ≥ 5 drinks on a single occasion within about 2 hours for men
- Use of recreational or street drugs
- Heavy smokers (≥ 20 cigarettes daily)
- Heavy caffeine users (> 400 mg a day, corresponding to about 4 or 5 cups of coffee)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality in a Non-clinical Population of Distressed Adults Reporting Poor Sleep: A Pilot Parallel-arm, Randomized Controlled Trial
The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.
Read the detailed description
Psychological distress is often associated with poor sleep quality. The role of psychological well-being has often been neglected and most interventions for sleep improvement have focused primarily on sleep disorders. This approach is limited to those individuals who have specific conditions and little resources have been directed to the promotion of sleep quality in the general population.
This study will be a pilot parallel-arm, randomized controlled trial to assess the baseline associations between psychological well-being and different measures of sleep outcomes, determine the effect of elements of a psychological well-being promoting intervention on sleep quality, and examine effect size estimates of key sleep-related outcomes (duration, efficiency, quality) to provide essential data to inform a main efficacy trial.
- Conditions
- Poor Quality Sleep
- Being tested
- Well-Being Intervention, Sleep Hygiene
- Keywords
- Sleep Quality, Psychological Distress, Psychological Well-Being, Well-Being Therapy, Sleep Hygiene
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being InterventionBehavioural
The main aim of the well-being intervention is to reduce levels of distress through the promotion of psychological well-being. Key components of the intervention are self-monitoring of instances of well-being and what leads to their interruption (i.e., thoughts and behaviors), cognitive restructuring of interfering thoughts, and homework assignments to address dysfunctional behaviors and increase exposure to optimal experiences. Participants will become aware of their functioning based on six different dimensions of psychological well-being (i.e., self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life, and personal growth), and will be guided in finding a balance within each dimension.
Sleep HygieneBehavioural
The main aim of sleep hygiene education is to provide participants with a set of behavioral and environmental recommendations intended to promote healthy sleep. During the intervention, participants will become aware of their own sleep patterns, will learn about healthy sleep habits, and will be encouraged to follow a set of recommendations to improve their sleep. Key components of the intervention are sleep hygiene and education.
| Study group | Role | What they receive |
|---|---|---|
| Well-Being and Sleep Hygiene | Experimental | Participants in the experimental group will receive an intervention focused on both principles of psychological well-being and sleep hygiene education. Receives: Behavioral: Well-Being Intervention; Behavioral: Sleep Hygiene |
| Sleep Hygiene (Control) | Active comparator | Participants in the control group will receive sleep hygiene education alone. Receives: Behavioral: Sleep Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Measured by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rating scale for the assessment of sleep quality over a 1-month time interval. The PSQI yields 7 component scores and one global score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is given a score from 0-3. The global score is calculated by summing the seven component scores, providing an overall score ranging from 0-21, where lower scores indicate a higher sleep quality.
Measured: Baseline to immediate post-intervention
Change in insomnia severity: Insomnia Severity Index (ISI)
Measured by the Insomnia Severity Index (ISI), a 7-item self-rated questionnaire to measure insomnia severity in the past 2 weeks. The total score ranges from 0-28, with higher scores indicating greater severity of insomnia. Scores of 8-14, 15-21, and 22-28 are indicative of subthreshold, moderate, and severe clinical insomnia, respectively.
Measured: Baseline to immediate post-intervention
Changes in total sleep time
Measured by self-reported sleep diary
Measured: Baseline to immediate post-intervention
Changes in sleep onset latency
Measured by self-reported sleep diary
Measured: Baseline to immediate post-intervention
Changes in wake after sleep onset
Measured by self-reported sleep diary
Measured: Baseline to immediate post-intervention
Secondary outcomes (2)
Change in psychological distress
Measured by the Symptom Questionnaire (SQ), a 92-item self-rating scale for the assessment of psychological distress over a 1-week time interval. The SQ yields 4 main scales: anxiety, depression, somatization, and hostility. Each scale can be further divided into 2 sub-scales: one concerned with symptoms (17 items) and the other with well-being (6 items). Answers on each item are dichotomous (i.e., yes/no or true false). Scales and subscales can be scored separately, and the sum of the 4 main scale scores yields a total distress score. A response of yes/true for a symptom item gives 1 point, and a response of no/false for a well-being question gives 1 point for a score ranging from 0-23 for each main scale and 0-17 for each subscale, where a higher score indicates greater distress. If the well-being score is calculated separately the raw score can be subtracted from 6 for a score ranging from 0-6, where a higher score indicates greater well-being.
Measured: Baseline to immediate post-intervention
Change in psychological well-being
Measured by the Psychological Well-being scale, a 42-item self-rating scale for the assessment of 6 dimensions of psychological well-being: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life, and personal growth. Each of the 42 six-point response items are given a score from 1-6, with questions phrased in the negative reversed (e.g., 1 to 6, 6 to 1). The total score in each dimension ranges from 7-42, and all the dimensions scores are summed to give a final total ranging from 42-252, with higher scores indicating greater psychological well-being.
Measured: Baseline to immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start28 Apr 2020
- Primary completion17 Jan 2021
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Poor Quality SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316663
- Sponsor's protocol ID
- AAAS8486
- Status last verified
- Apr 2023
- First submitted
- 18 Mar 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators can request de-identified data after the primary outcomes of this research project are published. Requests should be made in writing to the PI.
Publications
Almojali AI, Almalki SA, Alothman AS, Masuadi EM, Alaqeel MK. The prevalence and association of stress with sleep quality among medical students. J Epidemiol Glob Health. 2017 Sep;7(3):169-174. doi: 10.1016/j.jegh.2017.04.005. Epub 2017 May 5.
PubMed 28756825Bao YP, Han Y, Ma J, Wang RJ, Shi L, Wang TY, He J, Yue JL, Shi J, Tang XD, Lu L. Cooccurrence and bidirectional prediction of sleep disturbances and depression in older adults: Meta-analysis and systematic review. Neurosci Biobehav Rev. 2017 Apr;75:257-273. doi: 10.1016/j.neubiorev.2017.01.032. Epub 2017 Feb 6.
PubMed 28179129Bermudez-Millan A, Perez-Escamilla R, Segura-Perez S, Damio G, Chhabra J, Osborn CY, Wagner J. Psychological Distress Mediates the Association between Food Insecurity and Suboptimal Sleep Quality in Latinos with Type 2 Diabetes Mellitus. J Nutr. 2016 Oct;146(10):2051-2057. doi: 10.3945/jn.116.231365. Epub 2016 Aug 3.
PubMed 27489004Benasi G, Guidi J, Rafanelli C, Fava GA. New applications of Well-Being Therapy. Rivista Sperimentale di Freniatria, 1:87-106, 2019
Buysse DJ. Sleep health: can we define it? Does it matter? Sleep. 2014 Jan 1;37(1):9-17. doi: 10.5665/sleep.3298.
PubMed 24470692Chida Y, Steptoe A. Positive psychological well-being and mortality: a quantitative review of prospective observational studies. Psychosom Med. 2008 Sep;70(7):741-56. doi: 10.1097/PSY.0b013e31818105ba. Epub 2008 Aug 25.
PubMed 18725425Czeisler CA. Impact of sleepiness and sleep deficiency on public health--utility of biomarkers. J Clin Sleep Med. 2011 Oct 15;7(5 Suppl):S6-8. doi: 10.5664/JCSM.1340.
PubMed 22003334Fava GA, Sonino N. Psychosomatic assessment. Psychother Psychosom. 2009;78(6):333-41. doi: 10.1159/000235736. Epub 2009 Aug 27.
PubMed 19713727Fava GA. Well-Being Therapy treatment manual and clinical applications. Basel: Karger, 2016.
Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.
PubMed 27043240Franzen PL, Buysse DJ. Sleep disturbances and depression: risk relationships for subsequent depression and therapeutic implications. Dialogues Clin Neurosci. 2008;10(4):473-81. doi: 10.31887/DCNS.2008.10.4/plfranzen.
PubMed 19170404Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.
PubMed 25454674Jahoda M. Current concepts of positive mental health. New York, NY, US: Basic Books, 1958.
Leger D, Poursain B, Neubauer D, Uchiyama M. An international survey of sleeping problems in the general population. Curr Med Res Opin. 2008 Jan;24(1):307-17. doi: 10.1185/030079907x253771.
PubMed 18070379Lund HG, Reider BD, Whiting AB, Prichard JR. Sleep patterns and predictors of disturbed sleep in a large population of college students. J Adolesc Health. 2010 Feb;46(2):124-32. doi: 10.1016/j.jadohealth.2009.06.016. Epub 2009 Aug 3.
PubMed 20113918
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality in a Non-clinical Population of Distressed Adults Reporting Poor Sleep: A Pilot Parallel-arm, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04316663
- Acronym / sponsor ID
- AAAS8486
- Conditions
- Poor Quality Sleep
- Keywords
- Sleep Quality, Psychological Distress, Psychological Well-Being, Well-Being Therapy, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 20 Mar 2020 (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.
The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.
Detailed description
Psychological distress is often associated with poor sleep quality. The role of psychological well-being has often been neglected and most interventions for sleep improvement have focused primarily on sleep disorders. This approach is limited to those individuals who have specific conditions and little resources have been directed to the promotion of sleep quality in the general population.
This study will be a pilot parallel-arm, randomized controlled trial to assess the baseline associations between psychological well-being and different measures of sleep outcomes, determine the effect of elements of a psychological well-being promoting intervention on sleep quality, and examine effect size estimates of key sleep-related outcomes (duration, efficiency, quality) to provide essential data to inform a main efficacy trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Well-Being and Sleep Hygiene | Experimental | Behavioral: Well-Being Intervention, Behavioral: Sleep HygieneParticipants in the experimental group will receive an intervention focused on both principles of psychological well-being and sleep hygiene education. |
| Sleep Hygiene (Control) | Active comparator | Behavioral: Sleep HygieneParticipants in the control group will receive sleep hygiene education alone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years
- Distress according to the Perceived Stress Scale
- Poor sleep quality according to the Pittsburgh Sleep Quality Index
- No diagnosis of sleep disorders
- English fluency
Key exclusion criteria (16 listed)
- Inability to provide informed consent for any reason
- Cognitive impairment according to the Montreal Cognitive Assessment
- Suspected presence of sleep apnea according to the Berlin Questionnaire
- Diagnosis of a chronic medical or psychiatric condition
- Severe depression or suicidal thoughts or wishes according to the Beck Depression Inventory
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 |
|---|---|---|
| Well-Being InterventionThe main aim of the well-being intervention is to reduce levels of distress through the promotion of psychological well-being. Key components of the intervention are self-monitoring of instances of well-being and what leads to their interruption (i.e., thoughts and behaviors), cognitive restructuring of interfering thoughts, and homework assignments to address dysfunctional behaviors and increase exposure to optimal experiences. Participants will become aware of their functioning based on six different dimensions of psychological well-being (i.e., self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life, and personal growth), and will be guided in finding a balance within each dimension. | Behavioural | Well-Being and Sleep Hygiene |
| Sleep HygieneThe main aim of sleep hygiene education is to provide participants with a set of behavioral and environmental recommendations intended to promote healthy sleep. During the intervention, participants will become aware of their own sleep patterns, will learn about healthy sleep habits, and will be encouraged to follow a set of recommendations to improve their sleep. Key components of the intervention are sleep hygiene and education. | Behavioural | Sleep Hygiene (Control), Well-Being and Sleep Hygiene |
Primary outcome
Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline to immediate post-intervention
Measured by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rating scale for the assessment of sleep quality over a 1-month time interval. The PSQI yields 7 component scores and one global score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is given a score from 0-3. The global score is calculated by summing the seven component scores, providing an overall score ranging from 0-21, where lower scores indicate a higher sleep quality.
Change in insomnia severity: Insomnia Severity Index (ISI)
Time frame: Baseline to immediate post-intervention
Measured by the Insomnia Severity Index (ISI), a 7-item self-rated questionnaire to measure insomnia severity in the past 2 weeks. The total score ranges from 0-28, with higher scores indicating greater severity of insomnia. Scores of 8-14, 15-21, and 22-28 are indicative of subthreshold, moderate, and severe clinical insomnia, respectively.
Changes in total sleep time
Time frame: Baseline to immediate post-intervention
Measured by self-reported sleep diary
Changes in sleep onset latency
Time frame: Baseline to immediate post-intervention
Measured by self-reported sleep diary
Changes in wake after sleep onset
Time frame: Baseline to immediate post-intervention
Measured by self-reported sleep diary
2 secondary outcomes
Change in psychological distress
Time frame: Baseline to immediate post-intervention
Change in psychological well-being
Time frame: Baseline to immediate post-intervention
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 27 Apr 2023.
- Background: PubMed 28756825Almojali AI, Almalki SA, Alothman AS, Masuadi EM, Alaqeel MK. The prevalence and association of stress with sleep quality among medical students. J Epidemiol Glob Health. 2017 Sep;7(3):169-174. doi: 10.1016/j.jegh.2017.04.005. Epub 2017 May 5.
- Background: PubMed 28179129Bao YP, Han Y, Ma J, Wang RJ, Shi L, Wang TY, He J, Yue JL, Shi J, Tang XD, Lu L. Cooccurrence and bidirectional prediction of sleep disturbances and depression in older adults: Meta-analysis and systematic review. Neurosci Biobehav Rev. 2017 Apr;75:257-273. doi: 10.1016/j.neubiorev.2017.01.032. Epub 2017 Feb 6.
- Background: PubMed 27489004Bermudez-Millan A, Perez-Escamilla R, Segura-Perez S, Damio G, Chhabra J, Osborn CY, Wagner J. Psychological Distress Mediates the Association between Food Insecurity and Suboptimal Sleep Quality in Latinos with Type 2 Diabetes Mellitus. J Nutr. 2016 Oct;146(10):2051-2057. doi: 10.3945/jn.116.231365. Epub 2016 Aug 3.
- BackgroundBenasi G, Guidi J, Rafanelli C, Fava GA. New applications of Well-Being Therapy. Rivista Sperimentale di Freniatria, 1:87-106, 2019
- Background: PubMed 24470692Buysse DJ. Sleep health: can we define it? Does it matter? Sleep. 2014 Jan 1;37(1):9-17. doi: 10.5665/sleep.3298.
- Background: PubMed 18725425Chida Y, Steptoe A. Positive psychological well-being and mortality: a quantitative review of prospective observational studies. Psychosom Med. 2008 Sep;70(7):741-56. doi: 10.1097/PSY.0b013e31818105ba. Epub 2008 Aug 25.
- Background: PubMed 22003334Czeisler CA. Impact of sleepiness and sleep deficiency on public health--utility of biomarkers. J Clin Sleep Med. 2011 Oct 15;7(5 Suppl):S6-8. doi: 10.5664/JCSM.1340.
- Background: PubMed 19713727Fava GA, Sonino N. Psychosomatic assessment. Psychother Psychosom. 2009;78(6):333-41. doi: 10.1159/000235736. Epub 2009 Aug 27.
- BackgroundFava GA. Well-Being Therapy treatment manual and clinical applications. Basel: Karger, 2016.
- Background: PubMed 27043240Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.
- Background: PubMed 19170404Franzen PL, Buysse DJ. Sleep disturbances and depression: risk relationships for subsequent depression and therapeutic implications. Dialogues Clin Neurosci. 2008;10(4):473-81. doi: 10.31887/DCNS.2008.10.4/plfranzen.
- Background: PubMed 25454674Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.
- American Academy of Sleep MedicineLink provided by the sponsor.
- National Sleep FoundationLink provided by the sponsor.
- National Institute of HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Investigators can request de-identified data after the primary outcomes of this research project are published. Requests should be made in writing to the PI.
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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.
Marie-Pierre St-Onge, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-Being Intervention and Sleep Hygiene in people with Poor Quality Sleep, run by Columbia University at 1 site in United States.
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 6 inclusion and 16 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 27 Apr 2023. 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 United States. 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 quality: Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline to immediate post-intervention). 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?
On the ClinicalTrials.gov record for NCT04316663, which also lists 32 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 27 Apr 2023.