SleepNCT04417556
Validation of Various Sleep Assessment Tools in SICU
A study testing Sleep measurement in people with Sleep and Sleep Disturbance, run by Mahidol University at 1 site in Thailand.
Trial summary
Sleep deprivation is common in critical patients and it can cause impair consolidation of memory, cognitive function, metabolic function, immune, neurological and respiratory system as well as worsen the quality of life after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Sleep Disturbance, Sleep Deprivation
- What is being tested?
- Sleep measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient whose age ≥ 18 years old.
- Patients who are anticipated to stay in surgical intensive care unit at least one full night (from 8 p.m. to 6 a.m. next day).
- Patients who can answer the questionnaires and can communicate, read and write in Thai.
Who cannot join
- Patients with severe cognitive impairment, dementia, Richmond Agitation Sedation Scale (RASS) score of less than -2 or more than +1 or those receiving neuromuscular blocking agents.
- Patients with pathological lesions that preclude applying electrodes and sensors of polysomnography or applying actigraphy.
- Patients with high acuity of illness whose ICU survival is not expected.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
Official title: Validation of Sleep Assessment Tools in the Surgical Intensive Care Unit: Comparison of Thai Version of Richards-Campbell Sleep Questionnaire, Actigraphy, and Polysomnography
Sleep deprivation is common in critical patients and it can cause impair consolidation of memory, cognitive function, metabolic function, immune, neurological and respiratory system as well as worsen the quality of life after discharge. It has been demonstrated that reducing sleep disturbance could attenuate the development of delirium in ICU patients. However, sleep evaluation is only personal perception. There are various methods for sleep monitoring, in which the most commonly mentioned methods include polysomnography, actigraphy, and the Richards-Campbell Sleep Questionnaire (RCSQ). The aims of this study is to validate the accuracy of the Thai-version RCSQ and actigraphy for sleep measurement compared to polysomnography, which is considered as the gold-standard in Thai critically ill patients admitted to surgical intensive care unit.
Read the detailed description
Sleep is a periodic, reversible state of reduced consciousness, and response to external stimuli. A total sleep duration of normal human sleep is approximately 7-8 hours per night. Sleep deprivation is common in critical patients and it can cause impair consolidation of memory, cognitive function, metabolic function, immune, neurological and respiratory system as well as worsen the quality of life after discharge. The impact of sleep deprivation in critically ill patients is gaining attention as it links between sleep loss and delirium. It has been demonstrated that reducing sleep disturbance could attenuate the development of delirium in ICU patients. However, sleep evaluation is only personal perception and the previous study expressed that medical personnel evaluation still showed some error in approximately 56%. There are various methods for sleep monitoring, in which the most commonly mentioned methods include polysomnography, actigraphy, and the Richards-Campbell Sleep Questionnaire (RCSQ). Polysomnography is considered as the gold standard for monitoring the quantity and quality of sleep. Although, it is difficult to apply in critical care as it requires expensive setup and maintenance and is prone to patient dislodgment and electrical interference leading to low quality of signals and missed interpretation.
Nowadays, actigraphy has been used to assess patterns of rest and activity, which can distinguish sleep from wakefulness. The advantage of actigraphy is easy to use and non-invasive, can be used by non-specialists, and allows continuous measurement over days to weeks. On the other hand, its disadvantages are such as neuromuscular weakness and increases risk of overestimating sleep quantity as periods of inactivity scored as sleep. However, the technology has been improved recently leading to more accurate sleep measurement. Although it has been shown that actigraphy is a good alternative sleep measure in non-ICU patients, the accuracy of actigraphy is unknown in ICU patients.
For subjective tool for evaluating sleep, the Richards-Campbell Sleep Questionnaire (RCSQ) is one of the most commonly used questionnaires. It contains a simple five-item questionnaire which are sleep depth, ability to fall asleep, number of awakening, ability to fall asleep when awake and quality of sleep. The RCSQ shows a good correlation with polysomnography in sleep efficacy index. The advantages of RCSQ are easy-to-use, inexpensive and providing good quality of sleep assessment. It has been widely used in the United States and many countries. Moreover, it has been translated to many languages, such as Spanish, Swedish, German, and Japanese; and the translated version of RCSQ can be used as an alternative sleep measurement to polysomnography. Currently, our research group is translating the RCSQ into Thai version by using standard guidelines on the translation process. In spite of this, The Thai version of RCSQ (T-RCSQ) has not been validated with polysomnography before.
The aims of our study are to validate the accuracy of the T-RCSQ for sleep measurement compared to polysomnography, which is considered as the gold-standard and to access the accuracy of actigraphy for monitoring sleep quality and quantity compared to polysomnography in Thai critically ill patients admitted to surgical intensive care unit (SICU).
- Conditions
- Sleep, Sleep Disturbance, Sleep Deprivation, Polysomnography, Surveys and Questionnaires, Intensive Care Unit
- Being tested
- Sleep measurement
- Keywords
- Sleep Disturbance, Sleep Measurement Tools, Polysomnography, Actigraphy, Richards Campbell Questionnaire, Validation, Surgical Intensive Care Unit
- Medical subject headings
- Parasomnias, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep measurementDiagnostic test
Sleep measurement with polysomnography, actigraphy, and Thai-version Richards Campbell Sleep Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Measurement | Experimental | Sleep Measurement arm, sleep are simultaneously measured using polosomgraphy, actigraphy and Thai-version Richards Campbell Sleep Questionnaire. Receives: Diagnostic Test: Sleep measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time measured using polosomnography
Total sleep time measured using polysomnography from 8 pm until 6 am next day
Measured: 10 hours
Total sleep time measured using wrist actigraphy
Total sleep time measured using wrist actigraphy from 8 pm unitl 6 am next day
Measured: 10 hours
Sleep measurement using Thai-version Richards Campbell Sleep Questionnaire
Sleep measurement using five-item, visual analogue scale, Thai-version Richards Campbell Sleep Questionnaire, which range from 0 to 100 mm and the higher scores indicate a better quality of sleep.
Measured: 10 hours
Secondary outcomes (2)
Number of patients with sleep deprivation
Number of patients with sleep deprivation, which is defined as total sleep time of less than 5 hours measured using polysomnography
Measured: 10 hours
Sleep efficiency measured using polysomnography
Sleep efficiency measured using polysomnography from 8 pm until 6 am next day and defined as the ratio of total sleep time to time in bed.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jul 2020
- Primary completion30 Dec 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annop Piriyapatsom, MD, Mahidol University
- Investigators
- Annop Piriyapatsom, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417556
- Sponsor's protocol ID
- 103/2563(IRB2)
- Status last verified
- May 2022
- First submitted
- 1 Jun 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan of sharing.
Publications
Collop NA, Salas RE, Delayo M, Gamaldo C. Normal sleep and circadian processes. Crit Care Clin. 2008 Jul;24(3):449-60, v. doi: 10.1016/j.ccc.2008.02.002.
PubMed 18538194Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.
PubMed 12598213Mistraletti G, Carloni E, Cigada M, Zambrelli E, Taverna M, Sabbatini G, Umbrello M, Elia G, Destrebecq AL, Iapichino G. Sleep and delirium in the intensive care unit. Minerva Anestesiol. 2008 Jun;74(6):329-33.
PubMed 18500209Kamdar BB, Kamdar BB, Needham DM. Bundling sleep promotion with delirium prevention: ready for prime time? Anaesthesia. 2014 Jun;69(6):527-31. doi: 10.1111/anae.12686. No abstract available.
PubMed 24813131Weinhouse GL, Schwab RJ, Watson PL, Patil N, Vaccaro B, Pandharipande P, Ely EW. Bench-to-bedside review: delirium in ICU patients - importance of sleep deprivation. Crit Care. 2009;13(6):234. doi: 10.1186/cc8131. Epub 2009 Dec 7.
PubMed 20053301Nicolas A, Aizpitarte E, Iruarrizaga A, Vazquez M, Margall A, Asiain C. Perception of night-time sleep by surgical patients in an intensive care unit. Nurs Crit Care. 2008 Jan-Feb;13(1):25-33. doi: 10.1111/j.1478-5153.2007.00255.x.
PubMed 18226052Bourne RS, Minelli C, Mills GH, Kandler R. Clinical review: Sleep measurement in critical care patients: research and clinical implications. Crit Care. 2007;11(4):226. doi: 10.1186/cc5966.
PubMed 17764582Elliott R, McKinley S, Cistulli P, Fien M. Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.
PubMed 23506782Knauert MP, Yaggi HK, Redeker NS, Murphy TE, Araujo KL, Pisani MA. Feasibility study of unattended polysomnography in medical intensive care unit patients. Heart Lung. 2014 Sep-Oct;43(5):445-52. doi: 10.1016/j.hrtlng.2014.06.049. Epub 2014 Jul 12.
PubMed 25023504de Souza L, Benedito-Silva AA, Pires ML, Poyares D, Tufik S, Calil HM. Further validation of actigraphy for sleep studies. Sleep. 2003 Feb 1;26(1):81-5. doi: 10.1093/sleep/26.1.81.
PubMed 12627737Wolters AE, Slooter AJ, van der Kooi AW, van Dijk D. Cognitive impairment after intensive care unit admission: a systematic review. Intensive Care Med. 2013 Mar;39(3):376-86. doi: 10.1007/s00134-012-2784-9. Epub 2013 Jan 18.
PubMed 23328935Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PubMed 11227580Frisk U, Nordstrom G. Patients' sleep in an intensive care unit--patients' and nurses' perception. Intensive Crit Care Nurs. 2003 Dec;19(6):342-9. doi: 10.1016/s0964-3397(03)00076-4.
PubMed 14637294Krotsetis S, Richards KC, Behncke A, Kopke S. The reliability of the German version of the Richards Campbell Sleep Questionnaire. Nurs Crit Care. 2017 Jul;22(4):247-252. doi: 10.1111/nicc.12275. Epub 2017 Feb 6.
PubMed 28168810Murata H, Oono Y, Sanui M, Saito K, Yamaguchi Y, Takinami M, Richards KC, Henker R. The Japanese version of the Richards-Campbell Sleep Questionnaire: Reliability and validity assessment. Nurs Open. 2019 Mar 28;6(3):808-814. doi: 10.1002/nop2.252. eCollection 2019 Jul.
PubMed 31367403
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Sleep Assessment Tools in the Surgical Intensive Care Unit: Comparison of Thai Version of Richards-Campbell Sleep Questionnaire, Actigraphy, and Polysomnography
- ClinicalTrials.gov ID
- NCT04417556
- Acronym / sponsor ID
- 103/2563(IRB2)
- Conditions
- Sleep, Sleep Disturbance, Sleep Deprivation, Polysomnography, Surveys and Questionnaires, Intensive Care Unit
- Keywords
- Sleep Disturbance, Sleep Measurement Tools, Polysomnography, Actigraphy, Richards Campbell Questionnaire, Validation, Surgical Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 4 Jun 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.
Sleep deprivation is common in critical patients and it can cause impair consolidation of memory, cognitive function, metabolic function, immune, neurological and respiratory system as well as worsen the quality of life after discharge. It has been demonstrated that reducing sleep disturbance could attenuate the development of delirium in ICU patients. However, sleep evaluation is only personal perception. There are various methods for sleep monitoring, in which the most commonly mentioned methods include polysomnography, actigraphy, and the Richards-Campbell Sleep Questionnaire (RCSQ). The aims of this study is to validate the accuracy of the Thai-version RCSQ and actigraphy for sleep measurement compared to polysomnography, which is considered as the gold-standard in Thai critically ill patients admitted to surgical intensive care unit.
Detailed description
Sleep is a periodic, reversible state of reduced consciousness, and response to external stimuli. A total sleep duration of normal human sleep is approximately 7-8 hours per night. Sleep deprivation is common in critical patients and it can cause impair consolidation of memory, cognitive function, metabolic function, immune, neurological and respiratory system as well as worsen the quality of life after discharge. The impact of sleep deprivation in critically ill patients is gaining attention as it links between sleep loss and delirium. It has been demonstrated that reducing sleep disturbance could attenuate the development of delirium in ICU patients. However, sleep evaluation is only personal perception and the previous study expressed that medical personnel evaluation still showed some error in approximately 56%. There are various methods for sleep monitoring, in which the most commonly mentioned methods include polysomnography, actigraphy, and the Richards-Campbell Sleep Questionnaire (RCSQ). Polysomnography is considered as the gold standard for monitoring the quantity and quality of sleep. Although, it is difficult to apply in critical care as it requires expensive setup and maintenance and is prone to patient dislodgment and electrical interference leading to low quality of signals and missed interpretation.
Nowadays, actigraphy has been used to assess patterns of rest and activity, which can distinguish sleep from wakefulness. The advantage of actigraphy is easy to use and non-invasive, can be used by non-specialists, and allows continuous measurement over days to weeks. On the other hand, its disadvantages are such as neuromuscular weakness and increases risk of overestimating sleep quantity as periods of inactivity scored as sleep. However, the technology has been improved recently leading to more accurate sleep measurement. Although it has been shown that actigraphy is a good alternative sleep measure in non-ICU patients, the accuracy of actigraphy is unknown in ICU patients.
For subjective tool for evaluating sleep, the Richards-Campbell Sleep Questionnaire (RCSQ) is one of the most commonly used questionnaires. It contains a simple five-item questionnaire which are sleep depth, ability to fall asleep, number of awakening, ability to fall asleep when awake and quality of sleep. The RCSQ shows a good correlation with polysomnography in sleep efficacy index. The advantages of RCSQ are easy-to-use, inexpensive and providing good quality of sleep assessment. It has been widely used in the United States and many countries. Moreover, it has been translated to many languages, such as Spanish, Swedish, German, and Japanese; and the translated version of RCSQ can be used as an alternative sleep measurement to polysomnography. Currently, our research group is translating the RCSQ into Thai version by using standard guidelines on the translation process. In spite of this, The Thai version of RCSQ (T-RCSQ) has not been validated with polysomnography before.
The aims of our study are to validate the accuracy of the T-RCSQ for sleep measurement compared to polysomnography, which is considered as the gold-standard and to access the accuracy of actigraphy for monitoring sleep quality and quantity compared to polysomnography in Thai critically ill patients admitted to surgical intensive care unit (SICU).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Measurement | Experimental | Diagnostic Test: Sleep measurementSleep Measurement arm, sleep are simultaneously measured using polosomgraphy, actigraphy and Thai-version Richards Campbell Sleep Questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient whose age ≥ 18 years old.
- Patients who are anticipated to stay in surgical intensive care unit at least one full night (from 8 p.m. to 6 a.m. next day).
- Patients who can answer the questionnaires and can communicate, read and write in Thai.
Key exclusion criteria (3 listed)
- Patients with severe cognitive impairment, dementia, Richmond Agitation Sedation Scale (RASS) score of less than -2 or more than +1 or those receiving neuromuscular blocking agents.
- Patients with pathological lesions that preclude applying electrodes and sensors of polysomnography or applying actigraphy.
- Patients with high acuity of illness whose ICU survival is not expected.
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 measurementSleep measurement with polysomnography, actigraphy, and Thai-version Richards Campbell Sleep Questionnaire. | Diagnostic test | Sleep Measurement |
Primary outcome
Total sleep time measured using polosomnography
Time frame: 10 hours
Total sleep time measured using polysomnography from 8 pm until 6 am next day
Total sleep time measured using wrist actigraphy
Time frame: 10 hours
Total sleep time measured using wrist actigraphy from 8 pm unitl 6 am next day
Sleep measurement using Thai-version Richards Campbell Sleep Questionnaire
Time frame: 10 hours
Sleep measurement using five-item, visual analogue scale, Thai-version Richards Campbell Sleep Questionnaire, which range from 0 to 100 mm and the higher scores indicate a better quality of sleep.
2 secondary outcomes
Number of patients with sleep deprivation
Time frame: 10 hours
Sleep efficiency measured using polysomnography
Time frame: 10 hours
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 17 May 2022.
- Background: PubMed 18538194Collop NA, Salas RE, Delayo M, Gamaldo C. Normal sleep and circadian processes. Crit Care Clin. 2008 Jul;24(3):449-60, v. doi: 10.1016/j.ccc.2008.02.002.
- Background: PubMed 12598213Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.
- Background: PubMed 18500209Mistraletti G, Carloni E, Cigada M, Zambrelli E, Taverna M, Sabbatini G, Umbrello M, Elia G, Destrebecq AL, Iapichino G. Sleep and delirium in the intensive care unit. Minerva Anestesiol. 2008 Jun;74(6):329-33.
- Background: PubMed 24813131Kamdar BB, Kamdar BB, Needham DM. Bundling sleep promotion with delirium prevention: ready for prime time? Anaesthesia. 2014 Jun;69(6):527-31. doi: 10.1111/anae.12686. No abstract available.
- Background: PubMed 20053301Weinhouse GL, Schwab RJ, Watson PL, Patil N, Vaccaro B, Pandharipande P, Ely EW. Bench-to-bedside review: delirium in ICU patients - importance of sleep deprivation. Crit Care. 2009;13(6):234. doi: 10.1186/cc8131. Epub 2009 Dec 7.
- Background: PubMed 18226052Nicolas A, Aizpitarte E, Iruarrizaga A, Vazquez M, Margall A, Asiain C. Perception of night-time sleep by surgical patients in an intensive care unit. Nurs Crit Care. 2008 Jan-Feb;13(1):25-33. doi: 10.1111/j.1478-5153.2007.00255.x.
- Background: PubMed 17764582Bourne RS, Minelli C, Mills GH, Kandler R. Clinical review: Sleep measurement in critical care patients: research and clinical implications. Crit Care. 2007;11(4):226. doi: 10.1186/cc5966.
- Background: PubMed 23506782Elliott R, McKinley S, Cistulli P, Fien M. Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.
- Background: PubMed 25023504Knauert MP, Yaggi HK, Redeker NS, Murphy TE, Araujo KL, Pisani MA. Feasibility study of unattended polysomnography in medical intensive care unit patients. Heart Lung. 2014 Sep-Oct;43(5):445-52. doi: 10.1016/j.hrtlng.2014.06.049. Epub 2014 Jul 12.
- Background: PubMed 12627737de Souza L, Benedito-Silva AA, Pires ML, Poyares D, Tufik S, Calil HM. Further validation of actigraphy for sleep studies. Sleep. 2003 Feb 1;26(1):81-5. doi: 10.1093/sleep/26.1.81.
- Background: PubMed 23328935Wolters AE, Slooter AJ, van der Kooi AW, van Dijk D. Cognitive impairment after intensive care unit admission: a systematic review. Intensive Care Med. 2013 Mar;39(3):376-86. doi: 10.1007/s00134-012-2784-9. Epub 2013 Jan 18.
- Background: PubMed 11227580Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
- Individual participant dataSharing planned: No. There is no plan of sharing.
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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.
Annop Piriyapatsom, MD principal investigator
Mahidol 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 Sleep measurement in people with Sleep and Sleep Disturbance, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 3 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 17 May 2022. 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 Thailand. 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?
Total sleep time measured using polosomnography (time frame: 10 hours). The study lists 3 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 NCT04417556, which also lists 19 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 17 May 2022.