PrematurityNCT05711927
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
A study testing SNOO Smart Sleeper and Traditional bassinet in people with Prematurity and Very Preterm Maturity of Infant, run by Columbia University at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1. Do preterm infants who sleep in the SNOO have more quiet sleep? 2. Read more about this study
- Who is it for?
- Ages 1 week to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity, Very Preterm Maturity of Infant
- What is being tested?
- SNOO Smart Sleeper and Traditional bassinet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2023to 2 Jun 2025
- 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 1 week to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inpatients at the Morgan Stanley Children's Hospital NICU.
- Singleton gestation.
- Gestational age 28w0d to 36w6d at birth.
- Postmenstrual age greater than 35 weeks at the time of the intervention.
- Weight greater than 1.8 kg and less than 11.3 kg.
- Stable thermoregulation in an open crib.
- Stable respiratory status on room air (no nasal cannula or CPAP).
- Normal head ultrasound (if obtained).
Who cannot join
- Congenital brain or spinal anomalies.
- Intracranial hemorrhage.
- Severe encephalopathy.
- Known or suspected genetic syndromes that could result in cerebral dysfunction.
- Airway anomalies that could result in sleep-disordered breathing.
- Bleeding diatheses.
Show all 10Show fewer
- Status post surgery or minor surgical procedures (i.e. inguinal hernia repair, circumcision).
- Fetal opioid exposure.
- Administration of sedating agents over the past 24 hours.
- Ability to independently roll to hands and knees.
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian
New York, New York, 10032
About this study
Official title: The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are:
- Do preterm infants who sleep in the SNOO have more quiet sleep?
- Do preterm infants who sleep in the SNOO have improved vital signs?
Read more
- Participants will spend two separate three-hour periods sleeping in either a SNOO (which plays white noise and rocks from side-to-side) or in a SNOO that remains off (does not play white noise and does not move). There will be at least one week separating these sleep assessments.
- Participants will have their sleep stage and vital signs monitored (heart rate and oxygen levels).
- Participants will also wear two stickers on their forehead that measure brain oxygen levels (NIRS) and brain waves (EEG).
There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.
Read the detailed description
Sleep plays an important role in the brain growth and development of preterm infants. Neonatal sleep is made up of three stages of sleep: quiet sleep, active sleep, and transitional sleep. Poor sleep can be a result of premature birth itself as well as from simply being in the neonatal intensive care unit (NICU) environment. The interruptions that these infants are exposed to include frequent cares, physical exams, lights, and noises.
The investigators are interested in the potential positive effects on sleep of recreating the environment of the womb. The SNOO is a bassinet that uses the combination of a secure swaddle, white noise, and gentle rocking movements to mimic the conditions that infants were exposed to in the uterus before being born. The investigators are interested in studying how recreating this environment of "within the womb" impacts the sleep-wake cycles of premature infants. To do this, the investigators will measure the amount of time that premature infants spent asleep versus awake while in the SNOO through behavior observations, electroencephalogram (brain activity monitoring), and vital signs. The investigators hypothesize that sleeping in the SNOO will increase the amount of time that the premature infants spend in quiet sleep and will improve their vital signs.
- Conditions
- Prematurity, Very Preterm Maturity of Infant
- Being tested
- SNOO Smart Sleeper, Traditional bassinet
- Keywords
- sleep, SNOO, bassinet, white noise, rocking, swaddle, intrauterine environment, crying
- Medical subject headings
- Premature Birth, Stereotypic Movement Disorder, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNOO Smart SleeperDevice
Infants will be secured in the SNOO Sleep Sack. They will be placed in the center of the SNOO Smart Sleeper. The SNOO will be powered on and will start playing white noise and rocking from side-to-side. The SNOO's movement and sound settings will automatically ramp up and down as needed in response to the infant's sensed level of fussiness or crying per the manufacturer's programming. The "preemie mode" will be enabled, which caps motion at level 2 out of 5.
Traditional bassinetDevice
Infants will be swaddled using a standard hospital blanket. They will be placed in the center of the SNOO Smart Sleeper, but the SNOO will be left powered-off. No white noise will be played. No side-to-side rocking motions will occur.
| Study group | Role | What they receive |
|---|---|---|
| SNOO group | Experimental | The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. Receives: Device: SNOO Smart Sleeper |
| Traditional bassinet group | Sham comparator | The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. Receives: Device: Traditional bassinet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Quiet Sleep Time During 3-hour Sleep Assessment
Quiet sleep is a marker of sleep maturation and will be measured by the researcher during the 3-hour-long sleep assessments. Quiet sleep defined as eyes closed with predominantly flaccid "rag doll" appearance, body movements limited to startles, and rhythmic jaw jerks lasting 1 to 2 seconds.
Measured: At baseline sleep assessment, up to 3 hours
Secondary outcomes (4)
Change in Heart Rate Variability
Heart rate variability is the fluctuation of beat-to-beat heart rate intervals over time and is a marker of autonomic nervous system maturation.
Measured: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Change in Cerebral Oxygenation
Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).
Measured: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Change in Oxygen Saturation
Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry.
Measured: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Change in Intermittent Hypoxemic Event Frequency
Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry.
Measured: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start16 Mar 2023
- Primary completion31 May 2024
- Study completion2 Jun 2025
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.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the traditional bassinet condition or the SNOO Smart Sleeper. Depending on the group to which they are assigned, participants will spend six hours total (divided between two time points) under either the traditional bassinet conditions or in the SNOO Smart Sleeper while having a sleep assessment performed. The first sleep assessment will occur at 35-36 weeks postmenstrual age, and the second will occur at term-equivalent age (37 weeks or greater). Each sleep assessment will last three hours and will occur between feeds (2:00 p.m. to 5:00 p.m.).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Happiest Baby, Inc.
- Responsible party
- Principal investigator, Rakesh Sahni, Columbia University
- Investigators
- Rakesh Sahni, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711927
- Sponsor's protocol ID
- AAAU2315
- Status last verified
- Aug 2026
- First submitted
- 25 Jan 2023
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Calciolari G, Montirosso R. The sleep protection in the preterm infants. J Matern Fetal Neonatal Med. 2011 Oct;24 Suppl 1:12-4. doi: 10.3109/14767058.2011.607563.
PubMed 21942583Santos J, Pearce SE, Stroustrup A. Impact of hospital-based environmental exposures on neurodevelopmental outcomes of preterm infants. Curr Opin Pediatr. 2015 Apr;27(2):254-60. doi: 10.1097/MOP.0000000000000190.
PubMed 25635585Zhang X, Spear E, Hsu HL, Gennings C, Stroustrup A. NICU-based stress response and preterm infant neurobehavior: exploring the critical windows for exposure. Pediatr Res. 2022 Nov;92(5):1470-1478. doi: 10.1038/s41390-022-01983-3. Epub 2022 Feb 16.
PubMed 35173301Johnson S, Marlow N. Preterm birth and childhood psychiatric disorders. Pediatr Res. 2011 May;69(5 Pt 2):11R-8R. doi: 10.1203/PDR.0b013e318212faa0.
PubMed 21289534Smith GC, Gutovich J, Smyser C, Pineda R, Newnham C, Tjoeng TH, Vavasseur C, Wallendorf M, Neil J, Inder T. Neonatal intensive care unit stress is associated with brain development in preterm infants. Ann Neurol. 2011 Oct;70(4):541-9. doi: 10.1002/ana.22545. Epub 2011 Oct 4.
PubMed 21976396Restin T, Gaspar M, Bassler D, Kurtcuoglu V, Scholkmann F, Haslbeck FB. Newborn Incubators Do Not Protect from High Noise Levels in the Neonatal Intensive Care Unit and Are Relevant Noise Sources by Themselves. Children (Basel). 2021 Aug 16;8(8):704. doi: 10.3390/children8080704.
PubMed 34438595Spencer JA, Moran DJ, Lee A, Talbert D. White noise and sleep induction. Arch Dis Child. 1990 Jan;65(1):135-7. doi: 10.1136/adc.65.1.135.
PubMed 2405784Dereymaeker A, Pillay K, Vervisch J, De Vos M, Van Huffel S, Jansen K, Naulaers G. Review of sleep-EEG in preterm and term neonates. Early Hum Dev. 2017 Oct;113:87-103. doi: 10.1016/j.earlhumdev.2017.07.003. Epub 2017 Jul 12.
PubMed 28711233Weisman O, Magori-Cohen R, Louzoun Y, Eidelman AI, Feldman R. Sleep-wake transitions in premature neonates predict early development. Pediatrics. 2011 Oct;128(4):706-14. doi: 10.1542/peds.2011-0047. Epub 2011 Sep 12.
PubMed 21911350Barbeau DY, Weiss MD. Sleep Disturbances in Newborns. Children (Basel). 2017 Oct 20;4(10):90. doi: 10.3390/children4100090.
PubMed 29053622Kuhn P, Zores C, Pebayle T, Hoeft A, Langlet C, Escande B, Astruc D, Dufour A. Infants born very preterm react to variations of the acoustic environment in their incubator from a minimum signal-to-noise ratio threshold of 5 to 10 dBA. Pediatr Res. 2012 Apr;71(4 Pt 1):386-92. doi: 10.1038/pr.2011.76. Epub 2012 Feb 15.
PubMed 22391640Zores C, Dufour A, Pebayle T, Dahan I, Astruc D, Kuhn P. Observational study found that even small variations in light can wake up very preterm infants in a neonatal intensive care unit. Acta Paediatr. 2018 Jul;107(7):1191-1197. doi: 10.1111/apa.14261. Epub 2018 Feb 27.
PubMed 29412484Levy J, Hassan F, Plegue MA, Sokoloff MD, Kushwaha JS, Chervin RD, Barks JD, Shellhaas RA. Impact of hands-on care on infant sleep in the neonatal intensive care unit. Pediatr Pulmonol. 2017 Jan;52(1):84-90. doi: 10.1002/ppul.23513. Epub 2016 Jun 30.
PubMed 27362468
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants
- ClinicalTrials.gov ID
- NCT05711927
- Acronym / sponsor ID
- AAAU2315
- Conditions
- Prematurity, Very Preterm Maturity of Infant
- Keywords
- sleep, SNOO, bassinet, white noise, rocking, swaddle, intrauterine environment, crying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Happiest Baby, Inc.
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are:
- Do preterm infants who sleep in the SNOO have more quiet sleep?
- Do preterm infants who sleep in the SNOO have improved vital signs?
- Participants will spend two separate three-hour periods sleeping in either a SNOO (which plays white noise and rocks from side-to-side) or in a SNOO that remains off (does not play white noise and does not move). There will be at least one week separating these sleep assessments.
- Participants will have their sleep stage and vital signs monitored (heart rate and oxygen levels).
- Participants will also wear two stickers on their forehead that measure brain oxygen levels (NIRS) and brain waves (EEG).
There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.
Detailed description
Sleep plays an important role in the brain growth and development of preterm infants. Neonatal sleep is made up of three stages of sleep: quiet sleep, active sleep, and transitional sleep. Poor sleep can be a result of premature birth itself as well as from simply being in the neonatal intensive care unit (NICU) environment. The interruptions that these infants are exposed to include frequent cares, physical exams, lights, and noises.
The investigators are interested in the potential positive effects on sleep of recreating the environment of the womb. The SNOO is a bassinet that uses the combination of a secure swaddle, white noise, and gentle rocking movements to mimic the conditions that infants were exposed to in the uterus before being born. The investigators are interested in studying how recreating this environment of "within the womb" impacts the sleep-wake cycles of premature infants. To do this, the investigators will measure the amount of time that premature infants spent asleep versus awake while in the SNOO through behavior observations, electroencephalogram (brain activity monitoring), and vital signs. The investigators hypothesize that sleeping in the SNOO will increase the amount of time that the premature infants spend in quiet sleep and will improve their vital signs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the traditional bassinet condition or the SNOO Smart Sleeper. Depending on the group to which they are assigned, participants will spend six hours total (divided between two time points) under either the traditional bassinet conditions or in the SNOO Smart Sleeper while having a sleep assessment performed. The first sleep assessment will occur at 35-36 weeks postmenstrual age, and the second will occur at term-equivalent age (37 weeks or greater). Each sleep assessment will last three hours and will occur between feeds (2:00 p.m. to 5:00 p.m.).
| Arm | Type | Receives |
|---|---|---|
| SNOO group | Experimental | Device: SNOO Smart SleeperThe SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. |
| Traditional bassinet group | Sham comparator | Device: Traditional bassinetThe SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. |
Who may qualify
- Ages
- 1 week to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Inpatients at the Morgan Stanley Children's Hospital NICU.
- Singleton gestation.
- Gestational age 28w0d to 36w6d at birth.
- Postmenstrual age greater than 35 weeks at the time of the intervention.
- Weight greater than 1.8 kg and less than 11.3 kg.
Key exclusion criteria (10 listed)
- Congenital brain or spinal anomalies.
- Intracranial hemorrhage.
- Severe encephalopathy.
- Known or suspected genetic syndromes that could result in cerebral dysfunction.
- Airway anomalies that could result in sleep-disordered breathing.
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 |
|---|---|---|
| SNOO Smart SleeperInfants will be secured in the SNOO Sleep Sack. They will be placed in the center of the SNOO Smart Sleeper. The SNOO will be powered on and will start playing white noise and rocking from side-to-side. The SNOO's movement and sound settings will automatically ramp up and down as needed in response to the infant's sensed level of fussiness or crying per the manufacturer's programming. The "preemie mode" will be enabled, which caps motion at level 2 out of 5. | Device | SNOO group |
| Traditional bassinetInfants will be swaddled using a standard hospital blanket. They will be placed in the center of the SNOO Smart Sleeper, but the SNOO will be left powered-off. No white noise will be played. No side-to-side rocking motions will occur. | Device | Traditional bassinet group |
Primary outcome
Percent of Quiet Sleep Time During 3-hour Sleep Assessment
Time frame: At baseline sleep assessment, up to 3 hours
Quiet sleep is a marker of sleep maturation and will be measured by the researcher during the 3-hour-long sleep assessments. Quiet sleep defined as eyes closed with predominantly flaccid "rag doll" appearance, body movements limited to startles, and rhythmic jaw jerks lasting 1 to 2 seconds.
4 secondary outcomes
Change in Heart Rate Variability
Time frame: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Change in Cerebral Oxygenation
Time frame: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Change in Oxygen Saturation
Time frame: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Change in Intermittent Hypoxemic Event Frequency
Time frame: At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21942583Calciolari G, Montirosso R. The sleep protection in the preterm infants. J Matern Fetal Neonatal Med. 2011 Oct;24 Suppl 1:12-4. doi: 10.3109/14767058.2011.607563.
- Background: PubMed 25635585Santos J, Pearce SE, Stroustrup A. Impact of hospital-based environmental exposures on neurodevelopmental outcomes of preterm infants. Curr Opin Pediatr. 2015 Apr;27(2):254-60. doi: 10.1097/MOP.0000000000000190.
- Background: PubMed 35173301Zhang X, Spear E, Hsu HL, Gennings C, Stroustrup A. NICU-based stress response and preterm infant neurobehavior: exploring the critical windows for exposure. Pediatr Res. 2022 Nov;92(5):1470-1478. doi: 10.1038/s41390-022-01983-3. Epub 2022 Feb 16.
- Background: PubMed 21289534Johnson S, Marlow N. Preterm birth and childhood psychiatric disorders. Pediatr Res. 2011 May;69(5 Pt 2):11R-8R. doi: 10.1203/PDR.0b013e318212faa0.
- Background: PubMed 21976396Smith GC, Gutovich J, Smyser C, Pineda R, Newnham C, Tjoeng TH, Vavasseur C, Wallendorf M, Neil J, Inder T. Neonatal intensive care unit stress is associated with brain development in preterm infants. Ann Neurol. 2011 Oct;70(4):541-9. doi: 10.1002/ana.22545. Epub 2011 Oct 4.
- Background: PubMed 34438595Restin T, Gaspar M, Bassler D, Kurtcuoglu V, Scholkmann F, Haslbeck FB. Newborn Incubators Do Not Protect from High Noise Levels in the Neonatal Intensive Care Unit and Are Relevant Noise Sources by Themselves. Children (Basel). 2021 Aug 16;8(8):704. doi: 10.3390/children8080704.
- Background: PubMed 2405784Spencer JA, Moran DJ, Lee A, Talbert D. White noise and sleep induction. Arch Dis Child. 1990 Jan;65(1):135-7. doi: 10.1136/adc.65.1.135.
- Background: PubMed 28711233Dereymaeker A, Pillay K, Vervisch J, De Vos M, Van Huffel S, Jansen K, Naulaers G. Review of sleep-EEG in preterm and term neonates. Early Hum Dev. 2017 Oct;113:87-103. doi: 10.1016/j.earlhumdev.2017.07.003. Epub 2017 Jul 12.
- Background: PubMed 21911350Weisman O, Magori-Cohen R, Louzoun Y, Eidelman AI, Feldman R. Sleep-wake transitions in premature neonates predict early development. Pediatrics. 2011 Oct;128(4):706-14. doi: 10.1542/peds.2011-0047. Epub 2011 Sep 12.
- Background: PubMed 29053622Barbeau DY, Weiss MD. Sleep Disturbances in Newborns. Children (Basel). 2017 Oct 20;4(10):90. doi: 10.3390/children4100090.
- Background: PubMed 22391640Kuhn P, Zores C, Pebayle T, Hoeft A, Langlet C, Escande B, Astruc D, Dufour A. Infants born very preterm react to variations of the acoustic environment in their incubator from a minimum signal-to-noise ratio threshold of 5 to 10 dBA. Pediatr Res. 2012 Apr;71(4 Pt 1):386-92. doi: 10.1038/pr.2011.76. Epub 2012 Feb 15.
- Background: PubMed 29412484Zores C, Dufour A, Pebayle T, Dahan I, Astruc D, Kuhn P. Observational study found that even small variations in light can wake up very preterm infants in a neonatal intensive care unit. Acta Paediatr. 2018 Jul;107(7):1191-1197. doi: 10.1111/apa.14261. Epub 2018 Feb 27.
- 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.
Rakesh Sahni, MD 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 SNOO Smart Sleeper and Traditional bassinet in people with Prematurity and Very Preterm Maturity of Infant, 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 8 inclusion and 10 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 25 Sep 2026. 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. Some participants in this study may receive a placebo. 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 15 Sep 2025). 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?
Percent of Quiet Sleep Time During 3-hour Sleep Assessment (time frame: At baseline sleep assessment, up to 3 hours). 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 NCT05711927, which also lists 13 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 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.