Infant Sleep ProblemNCT04048785
Behavioral Sleep Intervention and Infant Sleep and Social-emotional Development
A study testing Behavioral sleep intervention in people with Infant Sleep Problem, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
An estimated 30-50% of infants have frequent problematic night wakings. Sleep disturbances have been linked to various adverse outcomes in children, including social-emotional development delay. Read more about this study
- Who is it for?
- Ages 5 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Sleep Problem
- What is being tested?
- Behavioral sleep intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Dec 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 5 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant age range 5-18 months;
- Sleep problem lasting at least 2 weeks, manifested in an average of ≥30 minutes sleep onset latency, and/or ≥2 awakenings per night based on parent reports;
- Both mother and father willing to participate in study procedures.
Who cannot join
- Infant pervasive developmental disorder or significant medical illness;
- Any concurrent treatment for infant sleep problems.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Shanghai, Shanghai Municipality
fan jiang, PhD, 021-58750573, fanjiang@shsmu.edu.cn
About this study
Official title: The Effects of Behavioral Sleep Intervention on Infant Sleep and Social-emotional Development
An estimated 30-50% of infants have frequent problematic night wakings. Sleep disturbances have been linked to various adverse outcomes in children, including social-emotional development delay. Despite some evidence of the effectiveness of Infant behavioral sleep intervention, the benefits on children's social-emotional development are worthy of further exploration. The aim of this study is to evaluate the efficacy of behavioral sleep interventions on improving infant sleep and social-emotional development. Infants with behavioral sleep disturbances are randomized into one of the two conditions: Behavioral sleep intervention or no treatment. And infant sleep and social-emotional development were assessed for both group at baseline, and four and eight weeks after sleep intervention.
Read the detailed description
Study Design: The study design was a parallel group RCT with two groups (Behavioral sleep intervention and Control) and three assessment points. Sleep was assessed by actigraphy (and sleep daily) and parent-reported Brief Infant Sleep Questionnaire (BISQ) during the week before behavioral sleep intervention, four weeks and eight weeks after sleep intervention. Other measures were collected during a laboratory visit scheduled at the end of each of the three assessment.
Participants: Participants were recruited through web-based media advertisements. Approximately 100 participants will be randomized to behavioral sleep intervention condition or a control condition. Inclusion criteria were: 1) infant age range 5-18 months; 2) significant sleep problem lasting at least 2 weeks, manifested in an average of ≥30 minutes sleep onset latency, and/or ≥2 awakenings per night based on parent reports; and 3) two-parent families with both mother and father willing to participate in study procedures. Exclusion criteria were: 1) infant pervasive developmental disorder or significant medical illness; and 2) any concurrent treatment for infant sleep problems.
Study Procedure: Participants are screened via telephone. Caregivers of the intervention group were instructed to establish tailored behavioral sleep intervention strategies. Control families received no sleep intervention. For infants with sleep problems in control group, any sleep treatment in health care services should be recorded. Infant social-emotional development were assessed by Ages \& Stages Questionnaires: Social-Emotional2 (ASQ:SE2) and behaviors in Still face experiment. During the experiment, the mother and infant engage in a three-step interaction: 1) playing"peek-a-boo" for 60 seconds; 2) mother maintaining a neutral facial expression while looking at the child, not smiling, talking, or touching for 120 seconds still-face (SF) episode; 3) maternal re-engagement with the infant to"peek-a-boo" for a 60 seconds reunion (RE) episode. The study was approved by the Institutional Review Board of Shanghai Children's Medical Center and all parents provided written informed consent.
Intervention: One clinical psychologist and one pediatrician delivered the intervention. The intervention was performed at Shanghai Children's Medical Center after parents signed the informed consent form. Interventionists collaborate with the family to design a tailored sleep intervention strategy, which involves appropriate sleep schedule and bedtime routine, putting the child to bed while still sleepy rather than when already asleep, caregivers should minimize their involvement after putting the infant to bed, and waiting 1 to 2 minutes before attending to the child during nocturnal awakenings. Parents are educated to implement the behavioral protocol at bedtime and subsequent night wakings. Furthermore, families of intervention group received a e-booklet describing their intervention and cell phone support weekly.
Measures: Infant sleep is assessed by Actigraphy and parent-report (sleep diary and Brief Infant Sleep Questionnaire, BISQ); Infant social-emotional development is evaluated by Ages \& Stages Questionnaires: Social-Emotional2 (ASQ:SE2), and behaviors (facial expression, gaze, and self-comforting) in three separate dimensions during the Still face experiment.
- Conditions
- Infant Sleep Problem
- Being tested
- Behavioral sleep intervention
- Keywords
- Child health care, Behavior sleep intervention, Mental health, Social emotional development
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral sleep interventionOther
The intervention consists of an infant behavioral sleep protocol. In the tailored intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys |
| Infant behavioral sleep intervention | Experimental | Interventionists collaborate with the family to design a tailored sleep intervention strategy, which involves appropriate sleep schedule and bedtime routine, putting the child to bed while still sleepy rather than when already asleep, and waiting 1 to 2 minutes before attending to the child during nocturnal awakenings. Parents are educated to implement the behavioral protocol at bedtime and subsequent night wakings. Receives: Other: Behavioral sleep intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant sleep measured by Actigraphy
Sleep-wake patterns are determined using actigraphy, which has been established as a valid method to objectively assess sleep in the infant's natural setting. Parents were asked to attach a actigraph (Motionlogger, Ambulatory Monitoring, Inc., Ardsley, NY, USA) to their child's ankle for 7 days at each assessment period. Data was scored using the Sadeh algorithm, which is the most commonly used analysis method in pediatric populations. Sleep diaries were completed by parents and used to identify and amend any irregularities in actigraphic data. The following actigraphic sleep metrics were used: 1) wake after sleep onset (WASO); 1) sleep of latency (SOL); and 3) number of awakenings (NW).
Measured: changes from baseline, 4 weeks and 8 weeks after the intervention
Infant sleep measured by Brief Infant Sleep Questionnaire
The BISQ is a well-validated sleep questionnaire aimed at assessing parent-reported infant sleep patterns. Parents completed the BISQ at each assessment point. The derived measures used in this study were: (1) sleep onset latency (SOL); (2) wake after sleep onset (WASO); and (3) number of awakenings.
Measured: changes from baseline, 4 weeks and 8 weeks after the intervention
Secondary outcomes (1)
Infant social-emotional development
ASQ:SE2 consists of a set of multiple choice questions that should be completed by caregivers of the infant. The questions are divided into forms according to age, and ask about behaviour in different areas: 1) self-regulation; 2) conformity; 3) adaptive functioning; 4) autonomy; 5) affect; 6) social communication; and 7) interaction with other persons. It makes it possible to detect if there is a risk in infant social-emotional development.
Developed as an ecologically-valid procedure for assessing emotion regulation (the foundation of the social-emotional development) in the context of parent-child interaction, the Still face procedure enables examination of infant modulation of affect, attention, and behavior in socially-stressful situations.
Measured: changes from baseline, 4 weeks and 8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Apr 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Infant Sleep ProblemStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiang Fan, PhD, Study chair, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048785
- Sponsor's protocol ID
- SCMCIRB-K2018013
- Status last verified
- Dec 2020
- First submitted
- 31 Jul 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Publications
Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
PubMed 23993280Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
PubMed 15939837Paap MC, Haraldsen IR, Breivik K, Butcher PR, Hellem FM, Stormark KM. The Link between Peer Relations, Prosocial Behavior, and ODD/ADHD Symptoms in 7-9-Year-Old Children. Psychiatry J. 2013;2013:319874. doi: 10.1155/2013/319874. Epub 2012 Dec 18.
PubMed 24286065Slomski A. Chronic mental health issues in children now loom larger than physical problems. JAMA. 2012 Jul 18;308(3):223-5. doi: 10.1001/jama.2012.6951. No abstract available.
PubMed 22797621Kahn M, Sheppes G, Sadeh A. Sleep and emotions: bidirectional links and underlying mechanisms. Int J Psychophysiol. 2013 Aug;89(2):218-28. doi: 10.1016/j.ijpsycho.2013.05.010. Epub 2013 May 24.
PubMed 23711996Baglioni C, Spiegelhalder K, Lombardo C, Riemann D. Sleep and emotions: a focus on insomnia. Sleep Med Rev. 2010 Aug;14(4):227-38. doi: 10.1016/j.smrv.2009.10.007. Epub 2010 Feb 6.
PubMed 20137989Yoo SS, Gujar N, Hu P, Jolesz FA, Walker MP. The human emotional brain without sleep--a prefrontal amygdala disconnect. Curr Biol. 2007 Oct 23;17(20):R877-8. doi: 10.1016/j.cub.2007.08.007. No abstract available.
PubMed 17956744Vandekerckhove M, Cluydts R. The emotional brain and sleep: an intimate relationship. Sleep Med Rev. 2010 Aug;14(4):219-26. doi: 10.1016/j.smrv.2010.01.002. Epub 2010 Apr 2.
PubMed 20363166Payne JD, Chambers AM, Kensinger EA. Sleep promotes lasting changes in selective memory for emotional scenes. Front Integr Neurosci. 2012 Nov 21;6:108. doi: 10.3389/fnint.2012.00108. eCollection 2012.
PubMed 23181013van der Helm E, Gujar N, Walker MP. Sleep deprivation impairs the accurate recognition of human emotions. Sleep. 2010 Mar;33(3):335-42. doi: 10.1093/sleep/33.3.335.
PubMed 20337191Zohar D, Tzischinski O, Epstein R. Effects of energy availability on immediate and delayed emotional reactions to work events. J Appl Psychol. 2003 Dec;88(6):1082-93. doi: 10.1037/0021-9010.88.6.1082.
PubMed 14640818Fernandez-Mendoza J, Vela-Bueno A, Vgontzas AN, Ramos-Platon MJ, Olavarrieta-Bernardino S, Bixler EO, De la Cruz-Troca JJ. Cognitive-emotional hyperarousal as a premorbid characteristic of individuals vulnerable to insomnia. Psychosom Med. 2010 May;72(4):397-403. doi: 10.1097/PSY.0b013e3181d75319. Epub 2010 Apr 5.
PubMed 20368477Palmer CA, Alfano CA. Sleep and emotion regulation: An organizing, integrative review. Sleep Med Rev. 2017 Feb;31:6-16. doi: 10.1016/j.smrv.2015.12.006. Epub 2016 Jan 14.
PubMed 26899742Crichton GE, Symon B. Behavioral Management of Sleep Problems in Infants Under 6 Months--What Works? J Dev Behav Pediatr. 2016 Feb-Mar;37(2):164-71. doi: 10.1097/DBP.0000000000000257.
PubMed 26836644Heckman JJ. Schools, Skills, and Synapses. Econ Inq. 2008 Jun;46(3):289. doi: 10.1111/j.1465-7295.2008.00163.x.
PubMed 20119503
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Behavioral Sleep Intervention on Infant Sleep and Social-emotional Development
- ClinicalTrials.gov ID
- NCT04048785
- Acronym / sponsor ID
- SCMCIRB-K2018013
- Conditions
- Infant Sleep Problem
- Keywords
- Child health care, Behavior sleep intervention, Mental health, Social emotional development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Aug 2019 (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.
An estimated 30-50% of infants have frequent problematic night wakings. Sleep disturbances have been linked to various adverse outcomes in children, including social-emotional development delay. Despite some evidence of the effectiveness of Infant behavioral sleep intervention, the benefits on children's social-emotional development are worthy of further exploration. The aim of this study is to evaluate the efficacy of behavioral sleep interventions on improving infant sleep and social-emotional development. Infants with behavioral sleep disturbances are randomized into one of the two conditions: Behavioral sleep intervention or no treatment. And infant sleep and social-emotional development were assessed for both group at baseline, and four and eight weeks after sleep intervention.
Detailed description
Study Design: The study design was a parallel group RCT with two groups (Behavioral sleep intervention and Control) and three assessment points. Sleep was assessed by actigraphy (and sleep daily) and parent-reported Brief Infant Sleep Questionnaire (BISQ) during the week before behavioral sleep intervention, four weeks and eight weeks after sleep intervention. Other measures were collected during a laboratory visit scheduled at the end of each of the three assessment.
Participants: Participants were recruited through web-based media advertisements. Approximately 100 participants will be randomized to behavioral sleep intervention condition or a control condition. Inclusion criteria were: 1) infant age range 5-18 months; 2) significant sleep problem lasting at least 2 weeks, manifested in an average of ≥30 minutes sleep onset latency, and/or ≥2 awakenings per night based on parent reports; and 3) two-parent families with both mother and father willing to participate in study procedures. Exclusion criteria were: 1) infant pervasive developmental disorder or significant medical illness; and 2) any concurrent treatment for infant sleep problems.
Study Procedure: Participants are screened via telephone. Caregivers of the intervention group were instructed to establish tailored behavioral sleep intervention strategies. Control families received no sleep intervention. For infants with sleep problems in control group, any sleep treatment in health care services should be recorded. Infant social-emotional development were assessed by Ages \& Stages Questionnaires: Social-Emotional2 (ASQ:SE2) and behaviors in Still face experiment. During the experiment, the mother and infant engage in a three-step interaction: 1) playing"peek-a-boo" for 60 seconds; 2) mother maintaining a neutral facial expression while looking at the child, not smiling, talking, or touching for 120 seconds still-face (SF) episode; 3) maternal re-engagement with the infant to"peek-a-boo" for a 60 seconds reunion (RE) episode. The study was approved by the Institutional Review Board of Shanghai Children's Medical Center and all parents provided written informed consent.
Intervention: One clinical psychologist and one pediatrician delivered the intervention. The intervention was performed at Shanghai Children's Medical Center after parents signed the informed consent form. Interventionists collaborate with the family to design a tailored sleep intervention strategy, which involves appropriate sleep schedule and bedtime routine, putting the child to bed while still sleepy rather than when already asleep, caregivers should minimize their involvement after putting the infant to bed, and waiting 1 to 2 minutes before attending to the child during nocturnal awakenings. Parents are educated to implement the behavioral protocol at bedtime and subsequent night wakings. Furthermore, families of intervention group received a e-booklet describing their intervention and cell phone support weekly.
Measures: Infant sleep is assessed by Actigraphy and parent-report (sleep diary and Brief Infant Sleep Questionnaire, BISQ); Infant social-emotional development is evaluated by Ages \& Stages Questionnaires: Social-Emotional2 (ASQ:SE2), and behaviors (facial expression, gaze, and self-comforting) in three separate dimensions during the Still face experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys |
| Infant behavioral sleep intervention | Experimental | Other: Behavioral sleep interventionInterventionists collaborate with the family to design a tailored sleep intervention strategy, which involves appropriate sleep schedule and bedtime routine, putting the child to bed while still sleepy rather than when already asleep, and waiting 1 to 2 minutes before attending to the child during nocturnal awakenings. Parents are educated to implement the behavioral protocol at bedtime and subsequent night wakings. |
Who may qualify
- Ages
- 5 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant age range 5-18 months;
- Sleep problem lasting at least 2 weeks, manifested in an average of ≥30 minutes sleep onset latency, and/or ≥2 awakenings per night based on parent reports;
- Both mother and father willing to participate in study procedures.
Key exclusion criteria (2 listed)
- Infant pervasive developmental disorder or significant medical illness;
- Any concurrent treatment for infant sleep problems.
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 |
|---|---|---|
| Behavioral sleep interventionThe intervention consists of an infant behavioral sleep protocol. In the tailored intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings. | Other | Infant behavioral sleep intervention |
Primary outcome
Infant sleep measured by Actigraphy
Time frame: changes from baseline, 4 weeks and 8 weeks after the intervention
Sleep-wake patterns are determined using actigraphy, which has been established as a valid method to objectively assess sleep in the infant's natural setting. Parents were asked to attach a actigraph (Motionlogger, Ambulatory Monitoring, Inc., Ardsley, NY, USA) to their child's ankle for 7 days at each assessment period. Data was scored using the Sadeh algorithm, which is the most commonly used analysis method in pediatric populations. Sleep diaries were completed by parents and used to identify and amend any irregularities in actigraphic data. The following actigraphic sleep metrics were used: 1) wake after sleep onset (WASO); 1) sleep of latency (SOL); and 3) number of awakenings (NW).
Infant sleep measured by Brief Infant Sleep Questionnaire
Time frame: changes from baseline, 4 weeks and 8 weeks after the intervention
The BISQ is a well-validated sleep questionnaire aimed at assessing parent-reported infant sleep patterns. Parents completed the BISQ at each assessment point. The derived measures used in this study were: (1) sleep onset latency (SOL); (2) wake after sleep onset (WASO); and (3) number of awakenings.
1 secondary outcome
Infant social-emotional development
Time frame: changes from baseline, 4 weeks and 8 weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Background: PubMed 23993280Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
- Background: PubMed 15939837Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
- Background: PubMed 24286065Paap MC, Haraldsen IR, Breivik K, Butcher PR, Hellem FM, Stormark KM. The Link between Peer Relations, Prosocial Behavior, and ODD/ADHD Symptoms in 7-9-Year-Old Children. Psychiatry J. 2013;2013:319874. doi: 10.1155/2013/319874. Epub 2012 Dec 18.
- Background: PubMed 22797621Slomski A. Chronic mental health issues in children now loom larger than physical problems. JAMA. 2012 Jul 18;308(3):223-5. doi: 10.1001/jama.2012.6951. No abstract available.
- Background: PubMed 23711996Kahn M, Sheppes G, Sadeh A. Sleep and emotions: bidirectional links and underlying mechanisms. Int J Psychophysiol. 2013 Aug;89(2):218-28. doi: 10.1016/j.ijpsycho.2013.05.010. Epub 2013 May 24.
- Background: PubMed 20137989Baglioni C, Spiegelhalder K, Lombardo C, Riemann D. Sleep and emotions: a focus on insomnia. Sleep Med Rev. 2010 Aug;14(4):227-38. doi: 10.1016/j.smrv.2009.10.007. Epub 2010 Feb 6.
- Background: PubMed 17956744Yoo SS, Gujar N, Hu P, Jolesz FA, Walker MP. The human emotional brain without sleep--a prefrontal amygdala disconnect. Curr Biol. 2007 Oct 23;17(20):R877-8. doi: 10.1016/j.cub.2007.08.007. No abstract available.
- Background: PubMed 20363166Vandekerckhove M, Cluydts R. The emotional brain and sleep: an intimate relationship. Sleep Med Rev. 2010 Aug;14(4):219-26. doi: 10.1016/j.smrv.2010.01.002. Epub 2010 Apr 2.
- Background: PubMed 23181013Payne JD, Chambers AM, Kensinger EA. Sleep promotes lasting changes in selective memory for emotional scenes. Front Integr Neurosci. 2012 Nov 21;6:108. doi: 10.3389/fnint.2012.00108. eCollection 2012.
- Background: PubMed 20337191van der Helm E, Gujar N, Walker MP. Sleep deprivation impairs the accurate recognition of human emotions. Sleep. 2010 Mar;33(3):335-42. doi: 10.1093/sleep/33.3.335.
- Background: PubMed 14640818Zohar D, Tzischinski O, Epstein R. Effects of energy availability on immediate and delayed emotional reactions to work events. J Appl Psychol. 2003 Dec;88(6):1082-93. doi: 10.1037/0021-9010.88.6.1082.
- Background: PubMed 20368477Fernandez-Mendoza J, Vela-Bueno A, Vgontzas AN, Ramos-Platon MJ, Olavarrieta-Bernardino S, Bixler EO, De la Cruz-Troca JJ. Cognitive-emotional hyperarousal as a premorbid characteristic of individuals vulnerable to insomnia. Psychosom Med. 2010 May;72(4):397-403. doi: 10.1097/PSY.0b013e3181d75319. Epub 2010 Apr 5.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. not yet decided
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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.
Jiang Fan, PhD study chair
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral sleep intervention in people with Infant Sleep Problem, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 21 Dec 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Fan, PhD (021-38626161, fanjiang@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant sleep measured by Actigraphy (time frame: changes from baseline, 4 weeks and 8 weeks after the intervention). The study lists 2 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 NCT04048785, which also lists 22 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 21 Dec 2020.