SleepNCT02788630
Infant Sleep Hygiene Counseling Trial
A study testing Sleep hygiene counseling in people with Sleep, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
This study will evaluate the efficacy of an intervention to improve quality and duration of self-regulated nighttime sleep (the amount of time the child maintains a combination of uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental intervention). Read more about this study
- Who is it for?
- Ages 3 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep hygiene counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to May 2016
- 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 3 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be eligible to the trial the child will need to belong to the Pelotas 2015 Birth Cohort, to be born healthy (newborns that needed intensive care after birth and with any congenital malformations will be excluded) from a single pregnancy at gestational age 37 weeks or greater, and to sleep regularly on average less than 13 hours per 24 hours (daytime and nighttime sleep) at three months of age (as reported by the mother). The information on child sleep duration per 24 hours will be gathered during the interview with mothers from the entire cohort, by means of the answer to the questions: "How many hours does the child sleep from 7pm to 7am?" and "How many hours does the child sleep from 7am to 7pm?"as well as number and duration of daytime naps, number of wake episodes during the night and how long it takes to the child to fall sleep after a nocturnal awakening.
Who cannot join
- Because the potential effect of the programmed maternal physical activity during pregnancy over the sleep duration or over the poor-sleeper-newborn answer to the sleep trial is not known, newborns to mothers that participated at the PAMELA trial will not be eligible to the sleep trial. The PAMELA (Physical Activity for Mothers Enrolled in Longitudinal Analysis) is a randomized controlled trial nested in the Pelotas 2015 birth cohort planned to assess the effect of regular exercise during pregnancy on the prevention of hypertension, pre-eclampsia and preterm birth. Eligible pregnant women between the 16th and 20th week of gestation are allocated into control group (426 women who are advised to keep their usual daily activities) or intervention group (213 women who engage in an exercise program, three sessions a week).
- Also, because the sleep intervention will recommend a series of environmental improvements to ensure a restful sleep (no screen media, low noise and light), the intervention will be restricted to families living in households with at least one bedroom. Children in continued use of medicines that can alter the sleep architecture and/or lead to drowsiness, like anticonvulsivants, will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96020220
About this study
Official title: Infant Sleep Hygiene Counseling: A Randomized Controlled Trial
This study will evaluate the efficacy of an intervention to improve quality and duration of self-regulated nighttime sleep (the amount of time the child maintains a combination of uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental intervention).
Read the detailed description
The development of adequate sleep patterns is paramount to the optimal neurodevelopment, as well as to promote proper learning, develop memory and preserve cerebral plasticity. Factors that hinder sleep patterns can negatively influence the child's growth, neurological and motor development.
The investigators will conduct a randomized controlled trial within the 2015 Pelotas Birth Cohort. At the 3-month follow-up, children who sleep less than 13 hours per 24 hours (nighttime sleep and daytime naps) will be eligible for the study. The sample size was estimated at 276 children per arm. Nighttime self-regulated sleep duration will be evaluated at baseline (age 3 months) and at 6, 12 and 24 months using actigraphy and via a sleep diary completed by the mother. Following block randomization, mothers from the intervention group will be visited by a trained fieldworker who will deliver counseling on age-appropriate normal sleep behaviors, how to facilitate sleep onset and how to manage night awakenings.
- Conditions
- Sleep
- Being tested
- Sleep hygiene counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene counselingBehavioural
Also called Child sleep trial
The mothers of the eligible infants will be visited at home and will be invited to participate at the study. To those who sign the Consent Form (CF) a following visit will be scheduled to within 5 days. Between CF signature and the 5-day visit, the enrolled children will use an actigraph-device in the leg and the mothers will fill out a sleep diary registering the times of the day the child is asleep, awake, napping, and feeding. At the 5-day visit the child allocation in the trial (intervention or control group) will be uncovered and the sleep recommendations will be delivered to mothers in the intervention group. Phone calls on days 6 and 7 and a home visit on day 8 will be paid to support mothers for possible difficulties in implementing the recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Arm: Experimental: Intervention group Field workers trained in sleep hygiene counseling will advice the mothers randomly allocated to the intervention group. The intervention will be delivered at the child household and will include information on: Normal sleep behaviors during the first year of life; ideal conditions to promote sleep onset like environmental improvements that ensure restful sleep (no screen media, low noise and light); calming naptime routines and avoiding stimulating or stressing children just before naptime; practices that promote child self-regulation of sleep, including putting infants to sleep drowsy but awake; and how to handle nighttime awakenings. A booklet with the intervention content to aid the mother in implementing the intervention will be used. Receives: Behavioral: Sleep hygiene counseling |
| Control group | No intervention | Mothers randomly allocated to the control group will be visited at home following the same schedule as the intervention group. The control group will receive a written material describing the advantages of breastfeeding over maternal and child health. No advice in relation to child sleep hygiene will be delivered to the mothers from the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime self-regulated sleep duration at 6, 12 and 24 months of age
Nighttime self-regulated sleep duration is the maximum amount of time the child stays asleep or awake without awakening the parents at ages 6, 12 and 24 months. This outcome will be evaluated by using the actigraphy and diary records for 5 days. The Brief Infant Sleep Questionnaire (BISQ) will be used at these three visits.
Measured: Up to 24 months
Secondary outcomes (3)
Linear growth between age 3-12 and 12-24 months of age
The effect of the intervention on linear growth will be estimated by comparing conditional growth between groups. At 3, 12 and 24 months of age anthropometric evaluation will include measures of length and weight. Length will be measured using a foldable wooden infantometer, custom made for the study, using for measurement a nylon tape measure with 1 mm precision adhered to a groove carved into the body of the instrument. Mother and child weight will be measured using an electronic scale (150 kg capacity and 100 g precision), the mother being weighed first alone then holding the baby. The child's weight will be calculated as the difference between the two measures. The mother will be weighed clothed, but without heavy outfits, and clothes worn by the mother will be recorded. The child will be weighed undressed, whenever allowed by the mother. Otherwise, the child's clothing will be recorded.
Measured: Up to 24 months
Neurocognitive development at 12 and 24 months of age.
The holistic neurodevelopment assessment designed and implemented by the Intergrowth-21st Project (Intergrowth neurodevelopment assessment tool - INTER-NDA) will be used to measure cognitive, motor, language, behavioral, attention, and executive function outcomes in children at 24 months. The recently developed 12-month version of the instrument (Oxford neurodevelopment assessment tool - OX-NDA) will be used to assess the child neurodevelopment at 12 months of age.
Measured: Up to 24 months
Validation study of the Oxford neurodevelopment assessment tool (OX-NDA)
100 children aged 10-12 months from the 2015 Pelotas Birth Cohort will participate in a validation study in which the OX-NDA results will be compared to the results of the Bayley Scales of Infant and Toddler Development - Third Edition (BSDI-III) taken as the gold standard.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University of Sao Paulo, Hospital Nossa Senhora da Conceicao, University of Oxford
- Responsible party
- Principal investigator, Iná da Silva dos Santos, Federal University of Pelotas
- Investigators
- Bianca Del Ponte, PhD, Study chair, Federal University of PelotasSuélen Cruz, PhD, Study chair, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788630
- Sponsor's protocol ID
- 47/2014
- Status last verified
- Jun 2016
- First submitted
- 18 May 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Santos IS, Del-Ponte B, Tovo-Rodrigues L, Halal CS, Matijasevich A, Cruz S, Anselmi L, Silveira MF, Hallal PRC, Bassani DG. Effect of Parental Counseling on Infants' Healthy Sleep Habits in Brazil: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918062. doi: 10.1001/jamanetworkopen.2019.18062.
PubMed 31860110Santos IS, Bassani DG, Matijasevich A, Halal CS, Del-Ponte B, da Cruz SH, Anselmi L, Albernaz E, Fernandes M, Tovo-Rodrigues L, Silveira MF, Hallal PC. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial. BMC Psychiatry. 2016 Sep 2;16(1):307. doi: 10.1186/s12888-016-1016-1.
PubMed 27590170
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Sleep Hygiene Counseling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02788630
- Acronym / sponsor ID
- 47/2014
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Collaborators
- University of Toronto, University of Sao Paulo, Hospital Nossa Senhora da Conceicao, University of Oxford
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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 will evaluate the efficacy of an intervention to improve quality and duration of self-regulated nighttime sleep (the amount of time the child maintains a combination of uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental intervention).
Detailed description
The development of adequate sleep patterns is paramount to the optimal neurodevelopment, as well as to promote proper learning, develop memory and preserve cerebral plasticity. Factors that hinder sleep patterns can negatively influence the child's growth, neurological and motor development.
The investigators will conduct a randomized controlled trial within the 2015 Pelotas Birth Cohort. At the 3-month follow-up, children who sleep less than 13 hours per 24 hours (nighttime sleep and daytime naps) will be eligible for the study. The sample size was estimated at 276 children per arm. Nighttime self-regulated sleep duration will be evaluated at baseline (age 3 months) and at 6, 12 and 24 months using actigraphy and via a sleep diary completed by the mother. Following block randomization, mothers from the intervention group will be visited by a trained fieldworker who will deliver counseling on age-appropriate normal sleep behaviors, how to facilitate sleep onset and how to manage night awakenings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Sleep hygiene counselingArm: Experimental: Intervention group Field workers trained in sleep hygiene counseling will advice the mothers randomly allocated to the intervention group. The intervention will be delivered at the child household and will include information on: Normal sleep behaviors during the first year of life; ideal conditions to promote sleep onset like environmental improvements that ensure restful sleep (no screen media, low noise and light); calming naptime routines and avoiding stimulating or stressing children just before naptime; practices that promote child self-regulation of sleep, including putting infants to sleep drowsy but awake; and how to handle nighttime awakenings. A booklet with the intervention content to aid the mother in implementing the intervention will be used. |
| Control group | No intervention | –Mothers randomly allocated to the control group will be visited at home following the same schedule as the intervention group. The control group will receive a written material describing the advantages of breastfeeding over maternal and child health. No advice in relation to child sleep hygiene will be delivered to the mothers from the control group. |
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- To be eligible to the trial the child will need to belong to the Pelotas 2015 Birth Cohort, to be born healthy (newborns that needed intensive care after birth and with any congenital malformations will be excluded) from a single pregnancy at gestational age 37 weeks or greater, and to sleep regularly on average less than 13 hours per 24 hours (daytime and nighttime sleep) at three months of age (as reported by the mother). The information on child sleep duration per 24 hours will be gathered during the interview with mothers from the entire cohort, by means of the answer to the questions: "How many hours does the child sleep from 7pm to 7am?" and "How many hours does the child sleep from 7am to 7pm?"as well as number and duration of daytime naps, number of wake episodes during the night and how long it takes to the child to fall sleep after a nocturnal awakening.
Key exclusion criteria (2 listed)
- Because the potential effect of the programmed maternal physical activity during pregnancy over the sleep duration or over the poor-sleeper-newborn answer to the sleep trial is not known, newborns to mothers that participated at the PAMELA trial will not be eligible to the sleep trial. The PAMELA (Physical Activity for Mothers Enrolled in Longitudinal Analysis) is a randomized controlled trial nested in the Pelotas 2015 birth cohort planned to assess the effect of regular exercise during pregnancy on the prevention of hypertension, pre-eclampsia and preterm birth. Eligible pregnant women between the 16th and 20th week of gestation are allocated into control group (426 women who are advised to keep their usual daily activities) or intervention group (213 women who engage in an exercise program, three sessions a week).
- Also, because the sleep intervention will recommend a series of environmental improvements to ensure a restful sleep (no screen media, low noise and light), the intervention will be restricted to families living in households with at least one bedroom. Children in continued use of medicines that can alter the sleep architecture and/or lead to drowsiness, like anticonvulsivants, will be excluded.
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 hygiene counselingAlso: Child sleep trialThe mothers of the eligible infants will be visited at home and will be invited to participate at the study. To those who sign the Consent Form (CF) a following visit will be scheduled to within 5 days. Between CF signature and the 5-day visit, the enrolled children will use an actigraph-device in the leg and the mothers will fill out a sleep diary registering the times of the day the child is asleep, awake, napping, and feeding. At the 5-day visit the child allocation in the trial (intervention or control group) will be uncovered and the sleep recommendations will be delivered to mothers in the intervention group. Phone calls on days 6 and 7 and a home visit on day 8 will be paid to support mothers for possible difficulties in implementing the recommendations. | Behavioural | Intervention group |
Primary outcome
Nighttime self-regulated sleep duration at 6, 12 and 24 months of age
Time frame: Up to 24 months
Nighttime self-regulated sleep duration is the maximum amount of time the child stays asleep or awake without awakening the parents at ages 6, 12 and 24 months. This outcome will be evaluated by using the actigraphy and diary records for 5 days. The Brief Infant Sleep Questionnaire (BISQ) will be used at these three visits.
3 secondary outcomes
Linear growth between age 3-12 and 12-24 months of age
Time frame: Up to 24 months
Neurocognitive development at 12 and 24 months of age.
Time frame: Up to 24 months
Validation study of the Oxford neurodevelopment assessment tool (OX-NDA)
Time frame: Up to 12 months
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 15 Jun 2016.
- Derived from this study: PubMed 31860110Santos IS, Del-Ponte B, Tovo-Rodrigues L, Halal CS, Matijasevich A, Cruz S, Anselmi L, Silveira MF, Hallal PRC, Bassani DG. Effect of Parental Counseling on Infants' Healthy Sleep Habits in Brazil: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918062. doi: 10.1001/jamanetworkopen.2019.18062.
- Derived from this study: PubMed 27590170Santos IS, Bassani DG, Matijasevich A, Halal CS, Del-Ponte B, da Cruz SH, Anselmi L, Albernaz E, Fernandes M, Tovo-Rodrigues L, Silveira MF, Hallal PC. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial. BMC Psychiatry. 2016 Sep 2;16(1):307. doi: 10.1186/s12888-016-1016-1.
- Individual participant dataSharing planned: Undecided
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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.
Bianca Del Ponte, PhD study chair
Federal University of Pelotas
Suélen Cruz, PhD study chair
Federal University of Pelotas
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 hygiene counseling in people with Sleep, run by Federal University of Pelotas at 1 site in Brazil.
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 1 inclusion and 2 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 15 Jun 2016. 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 Brazil. 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?
Nighttime self-regulated sleep duration at 6, 12 and 24 months of age (time frame: Up to 24 months). 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 NCT02788630, which also lists 2 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 15 Jun 2016.