Sleep DeprivationNCT06399939
The Function of Biphasic Sleep in Infants
A study testing Nap and Wake in people with Sleep Deprivation, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
This study is designed to investigate developmental changes in naps and nap function on memory from 9 to 15 months of age. Memory is measured by a task in which the experimenter interacts with a toy and the measure of memory is whether the child imitates that action when given the toy. Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Nap and Wake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9 months at the time of enrollment
- normal birthweight (5.5 to 10 lbs) and gestational length (36-41 weeks)
- must be willing and able to return for testing in 3 and 6 months (e.g., no plans to move out of the area)
Who cannot join
- born premature (<36 weeks gestational age)
- receiving services due to developmental delays
- visual or motor disability
- score <85 on cognitive and language composite scales and/or <80 on the average of the two composites of the Bayley Scales of Infant Development Fourth Edition (BSID-IV) administered at the first session.
- Infants' motor development (gross and fine motor) will also be assessed using the BSID-IV, and an adjusted cutoff of 73 will be used to exclude infants with significant motor delays (given the motoric nature of the task).
- traveling beyond 1 time zone within 2 weeks prior to testing (phone screening)
Show all 9Show fewer
- fever or symptoms of respiratory illness at the time of testing (phone screening)
- physical handicap that interferes with assessments (vision, hearing impairment; phone screening)
- history of neurological injury such as history of seizures, brain tumor, or stroke (phone screening) Parents/guardians of potential participants will be contacted via phone and/or email, at which time the details of the study will be specified and inclusion/exclusion criteria will be reviewed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts, Amherst
Amherst, Massachusetts, 01003
Rebecca Spencer, PhD, 413-577-6128, rspencer@umass.edu
About this study
This study is designed to investigate developmental changes in naps and nap function on memory from 9 to 15 months of age. Memory is measured by a task in which the experimenter interacts with a toy and the measure of memory is whether the child imitates that action when given the toy. Sleep is assessed with a watch that detects motion which provides an estimate of sleep and a set of electrodes placed on the head that measures brain activity during sleep. Infants are recruited at 9 months and sleep and memory are measured again 3- and 6-months later. At each visit, memory is tested before and after a nap (either the morning or afternoon nap) and naps are recorded with the sleep electrodes.
Read the detailed description
Four days prior to the first session, an experimenter will meet the caregiver and infant (at the lab or at their home) to review procedures and complete the informed consent process. The infant will be fitted with the actigraph watch on the ankle. The caregiver will be given instructions on use of the actigraph watch and be left with questionnaires to complete (e.g., sleep diary, behavioral questionnaires). Four days later, the caregiver and infant will come to the sleep lab for their initial session. In wave 1 (9 months), caregiver-infant dyads will be scheduled to arrive ~1 hr prior to the infant's typical morning nap time. In later waves, if the infant is reported to have eliminated their morning nap, they will be scheduled to arrive ~1 hr prior to when the nap typically occurred before they transitioned out of the morning nap. Infants will be semi-randomly assigned to either the nap or wake condition. Following acclimation to the lab, the infant will be fitted with the polysomnography (electrode) cap. The infant will then complete the encoding and immediate recall phases of the deferred imitation (memory) task. The infant will then be either wake or nap promoted or allowed to follow their normal morning routine. Approximately 90 mins later (following nap waking and time to recover from sleep inertia), the deferred imitation task (recall) will take place.
The caregiver and infant will then have free time (lunch, playtime), with instructions to return to the lab (if they choose to leave; they are also offered access to the lab kitchen and lounge area) ~40 mins before the infant's typical afternoon nap. They will also be instructed to: (1) avoid letting the infant nap and report any sleep that occurred (this will also be monitored with actigraphy); (2) not partake in any unusually stimulating activities; and (3) to follow a routine feeding schedule during this time. When the dyad returns to the lab, the infant will again be equipped with the polysomnography cap and complete the encoding and immediate recall phases with a new set of items. The infant will then either be wake or nap promoted or allowed to follow their normal afternoon nap routine. Approximately 90 mins later (following nap and time to recover from sleep inertia), the delayed recall phase will take place. The infant and caregiver will return to the lab one week later to complete the other condition. The procedures will be repeated at 12 (>12 months and <13 months) and 15 months (>15 months and <16 months).
- Conditions
- Sleep Deprivation
- Being tested
- Nap, Wake
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapBehavioural
Naps are common but promoted by soothing, lying the infant down, and/or rocking and massaging
WakeBehavioural
Wake is encouraged by keeping the infant upright, providing stimulation (e.g., reading books, handing toys)
| Study group | Role | What they receive |
|---|---|---|
| Nap | Experimental | Naps are promoted Receives: Behavioral: Nap |
| Wake (non-nap) | Experimental | Wake is promoted Receives: Behavioral: Wake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory accuracy
Deferred imitation task accuracy (0-100%; higher is better memory)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Sep 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to morning or afternoon nap manipulation In each manipulation, participants complete a nap and a wake condition
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399939
- Sponsor's protocol ID
- 4320
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared using Databrary, an open data library for developmental behavioral scientists. As we seek to keep all aspects of the data in one place, all data will be shared via Databrary. Only data of participants who consent to having their data shared in Databrary will be entered there. Consent to Databrary sharing includes notification that video data cannot be completely confidential and they/their child may be recognized in the video. For this reason, caregivers will specifically consent to video sharing in addition to sharing of other data.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Function of Biphasic Sleep in Infants
- ClinicalTrials.gov ID
- NCT06399939
- Acronym / sponsor ID
- 4320
- Conditions
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- University of Maryland, College Park
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 6 May 2024 (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 designed to investigate developmental changes in naps and nap function on memory from 9 to 15 months of age. Memory is measured by a task in which the experimenter interacts with a toy and the measure of memory is whether the child imitates that action when given the toy. Sleep is assessed with a watch that detects motion which provides an estimate of sleep and a set of electrodes placed on the head that measures brain activity during sleep. Infants are recruited at 9 months and sleep and memory are measured again 3- and 6-months later. At each visit, memory is tested before and after a nap (either the morning or afternoon nap) and naps are recorded with the sleep electrodes.
Detailed description
Four days prior to the first session, an experimenter will meet the caregiver and infant (at the lab or at their home) to review procedures and complete the informed consent process. The infant will be fitted with the actigraph watch on the ankle. The caregiver will be given instructions on use of the actigraph watch and be left with questionnaires to complete (e.g., sleep diary, behavioral questionnaires). Four days later, the caregiver and infant will come to the sleep lab for their initial session. In wave 1 (9 months), caregiver-infant dyads will be scheduled to arrive ~1 hr prior to the infant's typical morning nap time. In later waves, if the infant is reported to have eliminated their morning nap, they will be scheduled to arrive ~1 hr prior to when the nap typically occurred before they transitioned out of the morning nap. Infants will be semi-randomly assigned to either the nap or wake condition. Following acclimation to the lab, the infant will be fitted with the polysomnography (electrode) cap. The infant will then complete the encoding and immediate recall phases of the deferred imitation (memory) task. The infant will then be either wake or nap promoted or allowed to follow their normal morning routine. Approximately 90 mins later (following nap waking and time to recover from sleep inertia), the deferred imitation task (recall) will take place.
The caregiver and infant will then have free time (lunch, playtime), with instructions to return to the lab (if they choose to leave; they are also offered access to the lab kitchen and lounge area) ~40 mins before the infant's typical afternoon nap. They will also be instructed to: (1) avoid letting the infant nap and report any sleep that occurred (this will also be monitored with actigraphy); (2) not partake in any unusually stimulating activities; and (3) to follow a routine feeding schedule during this time. When the dyad returns to the lab, the infant will again be equipped with the polysomnography cap and complete the encoding and immediate recall phases with a new set of items. The infant will then either be wake or nap promoted or allowed to follow their normal afternoon nap routine. Approximately 90 mins later (following nap and time to recover from sleep inertia), the delayed recall phase will take place. The infant and caregiver will return to the lab one week later to complete the other condition. The procedures will be repeated at 12 (>12 months and <13 months) and 15 months (>15 months and <16 months).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to morning or afternoon nap manipulation In each manipulation, participants complete a nap and a wake condition
| Arm | Type | Receives |
|---|---|---|
| Nap | Experimental | Behavioral: NapNaps are promoted |
| Wake (non-nap) | Experimental | Behavioral: WakeWake is promoted |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 9 months at the time of enrollment
- normal birthweight (5.5 to 10 lbs) and gestational length (36-41 weeks)
- must be willing and able to return for testing in 3 and 6 months (e.g., no plans to move out of the area)
Key exclusion criteria (9 listed)
- born premature (<36 weeks gestational age)
- receiving services due to developmental delays
- visual or motor disability
- score <85 on cognitive and language composite scales and/or <80 on the average of the two composites of the Bayley Scales of Infant Development Fourth Edition (BSID-IV) administered at the first session.
- Infants' motor development (gross and fine motor) will also be assessed using the BSID-IV, and an adjusted cutoff of 73 will be used to exclude infants with significant motor delays (given the motoric nature of the task).
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 |
|---|---|---|
| NapNaps are common but promoted by soothing, lying the infant down, and/or rocking and massaging | Behavioural | Nap |
| WakeWake is encouraged by keeping the infant upright, providing stimulation (e.g., reading books, handing toys) | Behavioural | Wake (non-nap) |
Primary outcome
Memory accuracy
Time frame: 4 hours
Deferred imitation task accuracy (0-100%; higher is better memory)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Yes. Data will be shared using Databrary, an open data library for developmental behavioral scientists. As we seek to keep all aspects of the data in one place, all data will be shared via Databrary. Only data of participants who consent to having their data shared in Databrary will be entered there. Consent to Databrary sharing includes notification that video data cannot be completely confidential and they/their child may be recognized in the video. For this reason, caregivers will specifically consent to video sharing in addition to sharing of other data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nap and Wake in people with Sleep Deprivation, run by University of Massachusetts, Amherst 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory accuracy (time frame: 4 hours). 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 8 May 2024.