NewbornNCT07423962
The Effect of Sleep Caps on Sleep and Physiological Parameters in Infants in the Neonatal Intensive Care Unit
A study testing Wearing a Sleep Cap in people with Newborn and Neonatal Intensive Care Unit, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled experimental trial designed to evaluate the effects of a researcher-developed sleep cap on the sleep and physiological variables of infants hospitalized in the Neonatal Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 32 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Newborn, Neonatal Intensive Care Unit, Neonatal Intensive Care
- What is being tested?
- Wearing a Sleep Cap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 31 Mar 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 32 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns who are over 32 weeks gestation and are hospitalized in the NICU
- Newborns stable in room air conditions
Who cannot join
- Premature infants birth under 32 weeks
- Newborns receiving phototherapy treatment
- Newborns receiving respiratory support
- Newborns with congenital anomalies
- Newborns receiving medication that affects sleep (such as caffeine)
- Newborns with sepsis
- Newborns with congenital diseases
- Newborns with diseases affecting the central nervous system
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing
Aydin, Efeler
About this study
Official title: The Effect of Wearing a Sleep Cap on the Sleep and Physiological Variables of Infants Hospitalized in the Neonatal Intensive Care Unit: A Randomized Controlled Experimental Study
This study is a randomized controlled experimental trial designed to evaluate the effects of a researcher-developed sleep cap on the sleep and physiological variables of infants hospitalized in the Neonatal Intensive Care Unit.
Read the detailed description
Sleep is a fundamental requirement for human physiological and psychological well-being. It is neurobiologically vital for brain development, neuroplasticity, motor and language development, learning, and memory. Newborns spend most of their time sleeping, and sleep is the primary behavioral state in the brain development of the newborn. Studies have shown that when newborn sleep is not preserved, neurobiological development, cognitive growth, and academic achievement are negatively affected in later stages of life.
Neonatal Intensive Care Units (NICUs), unlike the intrauterine environment, are stressful settings with bright lights, noise, and painful stimuli. These adverse stimuli negatively affect sleep, physiological parameters, growth, development, and the length of hospital stay. In NICUs, premature infants whose many systems are not yet fully developed are often treated. Therefore, preterm infants, in particular, need greater protection against the negative effects of the intensive care environment.
The literature contains many studies emphasizing the importance of preserving infants' sleep. However, it has been observed that there is no tool designed to simultaneously reduce the light and noise to which infants in intensive care are exposed, while also establishing a light-dark cycle to promote and preserve circadian rhythm development. In response to this need, researchers have developed a sleep cap. The aim of this study is to examine the effects of using this newly developed sleep cap on the sleep and physiological variables of infants hospitalized in the neonatal intensive care unit.
- Conditions
- Newborn, Neonatal Intensive Care Unit, Neonatal Intensive Care, Sleep, Physiological Parameters, Nursing Care
- Being tested
- Wearing a Sleep Cap
- Keywords
- Physiological variables, Newborn, sleep, Neonatal Intensive Care Unit, neonatal care, Nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing a Sleep CapOther
Demographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the study group were recorded. The newborns in the study group were fitted with sleeping caps for three days between 7:00 PM and 7:00 AM, and the caps were removed when they woke. 12 hours of uninterrupted video recording was conducted during this time. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study.
| Study group | Role | What they receive |
|---|---|---|
| Sleep caps group:Newborns in the experimental group were fitted sleep caps | Experimental | Demographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the study group were recorded. The newborns in the study group were fitted with sleeping hats for three days between 7:00 PM and 7:00 AM, and the hats were removed when they woke. 12 hours of uninterrupted video recording was conducted during this time. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study. Receives: Other: Wearing a Sleep Cap |
| Control group | No intervention | Demographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the control group were recorded. Newborns in the control group underwent clinical routines for three days, and uninterrupted video recordings were made between 7:00 PM and 7:00 AM. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant's Night Sleep Duration
The duration (in minutes) of continuous sleep between 19:00 and 07:00 was determined by watching video recordings from three days of monitoring. For each monitoring day, the average sleep duration (in minutes) over a 12-hour period (19:00-07:00) was determined.
Measured: For three days, between 19:00 and 07:00.
Number of Nighttime Awakenings of the Infants
During three monitoring days, the number of times the ınfant woke up between 19:00 and 07:00 was determined by watching video recordings. For each monitoring day, the number of awakenings in a 12-hour period (19:00-07:00) was determined.
Measured: For three days, between 19:00 and 07:00
Heart Rate
The infants' heart rate (beats per minute) was monitored using bedside monitors. For each monitoring day, a 12-hour average heart rate (beats per minute) was recorded (between 19:00 and 07:00).
Measured: For three days, between 19:00 and 07:00
Respiratory Rate
The respiratory rate (respiratory rate/minute) of the infants was monitored using bedside monitors. For each monitoring day, the average respiratory rate (respiratory rate/minute) was taken over 12 hours (between 19:00 and 07:00).
Measured: For three days, between 19:00 and 07:00
Oxygen saturation
Oxygen saturation (%) of infants was monitored with bedside monitors. For each monitoring day, the 12-hour (between 19:00 and 07:00) average oxygen saturation was taken (%).
Measured: For three days, between 19:00 and 07:00
Body Temperature
The infant's body temperature (°C) was measured with a thermometer suitable for infants. For each monitoring day, the 12-hour average body temperature (between 19:00 and 07:00) was taken (°C).
Measured: For three days, between 19:00 and 07:00
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- stratified randomization newborns between 32 and 37 weeks of gestation were matched stratified with newborns between 38 and 42 weeks of gestation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozkurt, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423962
- Sponsor's protocol ID
- Experimental Study 2019/158
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets that are continuously and/or analyzed during the current study can be obtained from the author upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wearing a Sleep Cap on the Sleep and Physiological Variables of Infants Hospitalized in the Neonatal Intensive Care Unit: A Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT07423962
- Acronym / sponsor ID
- Experimental Study 2019/158
- Conditions
- Newborn, Neonatal Intensive Care Unit, Neonatal Intensive Care, Sleep, Physiological Parameters, Nursing Care
- Keywords
- Physiological variables, Newborn, sleep, Neonatal Intensive Care Unit, neonatal care, Nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled experimental trial designed to evaluate the effects of a researcher-developed sleep cap on the sleep and physiological variables of infants hospitalized in the Neonatal Intensive Care Unit.
Detailed description
Sleep is a fundamental requirement for human physiological and psychological well-being. It is neurobiologically vital for brain development, neuroplasticity, motor and language development, learning, and memory. Newborns spend most of their time sleeping, and sleep is the primary behavioral state in the brain development of the newborn. Studies have shown that when newborn sleep is not preserved, neurobiological development, cognitive growth, and academic achievement are negatively affected in later stages of life.
Neonatal Intensive Care Units (NICUs), unlike the intrauterine environment, are stressful settings with bright lights, noise, and painful stimuli. These adverse stimuli negatively affect sleep, physiological parameters, growth, development, and the length of hospital stay. In NICUs, premature infants whose many systems are not yet fully developed are often treated. Therefore, preterm infants, in particular, need greater protection against the negative effects of the intensive care environment.
The literature contains many studies emphasizing the importance of preserving infants' sleep. However, it has been observed that there is no tool designed to simultaneously reduce the light and noise to which infants in intensive care are exposed, while also establishing a light-dark cycle to promote and preserve circadian rhythm development. In response to this need, researchers have developed a sleep cap. The aim of this study is to examine the effects of using this newly developed sleep cap on the sleep and physiological variables of infants hospitalized in the neonatal intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- stratified randomization newborns between 32 and 37 weeks of gestation were matched stratified with newborns between 38 and 42 weeks of gestation
| Arm | Type | Receives |
|---|---|---|
| Sleep caps group:Newborns in the experimental group were fitted sleep caps | Experimental | Other: Wearing a Sleep CapDemographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the study group were recorded. The newborns in the study group were fitted with sleeping hats for three days between 7:00 PM and 7:00 AM, and the hats were removed when they woke. 12 hours of uninterrupted video recording was conducted during this time. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study. |
| Control group | No intervention | –Demographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the control group were recorded. Newborns in the control group underwent clinical routines for three days, and uninterrupted video recordings were made between 7:00 PM and 7:00 AM. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study. |
Who may qualify
- Ages
- 32 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns who are over 32 weeks gestation and are hospitalized in the NICU
- Newborns stable in room air conditions
Key exclusion criteria (8 listed)
- Premature infants birth under 32 weeks
- Newborns receiving phototherapy treatment
- Newborns receiving respiratory support
- Newborns with congenital anomalies
- Newborns receiving medication that affects sleep (such as caffeine)
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 |
|---|---|---|
| Wearing a Sleep CapDemographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the study group were recorded. The newborns in the study group were fitted with sleeping caps for three days between 7:00 PM and 7:00 AM, and the caps were removed when they woke. 12 hours of uninterrupted video recording was conducted during this time. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study. | Other | Sleep caps group:Newborns in the experimental group were fitted sleep caps |
Primary outcome
Infant's Night Sleep Duration
Time frame: For three days, between 19:00 and 07:00.
The duration (in minutes) of continuous sleep between 19:00 and 07:00 was determined by watching video recordings from three days of monitoring. For each monitoring day, the average sleep duration (in minutes) over a 12-hour period (19:00-07:00) was determined.
Number of Nighttime Awakenings of the Infants
Time frame: For three days, between 19:00 and 07:00
During three monitoring days, the number of times the ınfant woke up between 19:00 and 07:00 was determined by watching video recordings. For each monitoring day, the number of awakenings in a 12-hour period (19:00-07:00) was determined.
Heart Rate
Time frame: For three days, between 19:00 and 07:00
The infants' heart rate (beats per minute) was monitored using bedside monitors. For each monitoring day, a 12-hour average heart rate (beats per minute) was recorded (between 19:00 and 07:00).
Respiratory Rate
Time frame: For three days, between 19:00 and 07:00
The respiratory rate (respiratory rate/minute) of the infants was monitored using bedside monitors. For each monitoring day, the average respiratory rate (respiratory rate/minute) was taken over 12 hours (between 19:00 and 07:00).
Oxygen saturation
Time frame: For three days, between 19:00 and 07:00
Oxygen saturation (%) of infants was monitored with bedside monitors. For each monitoring day, the 12-hour (between 19:00 and 07:00) average oxygen saturation was taken (%).
Body Temperature
Time frame: For three days, between 19:00 and 07:00
The infant's body temperature (°C) was measured with a thermometer suitable for infants. For each monitoring day, the 12-hour average body temperature (between 19:00 and 07:00) was taken (°C).
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 24 Feb 2026.
- Individual participant dataSharing planned: Yes. Datasets that are continuously and/or analyzed during the current study can be obtained from the author upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing a Sleep Cap in people with Newborn and Neonatal Intensive Care Unit, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 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 24 Feb 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant's Night Sleep Duration (time frame: For three days, between 19:00 and 07:00.). The study lists 6 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 24 Feb 2026.