InsomniaNCT03447665
Infant Behavioral Sleep Intervention: Comparative Efficacy
A study testing Bedtime routine, Sleep schedule and Intervention (bedtime) in people with Insomnia, run by Indiana University at 1 site in United States.
Trial summary
While frequent night awakenings in newborns are common and expected, an estimated 20-30% of older infants and toddlers have frequent problematic night wakings requiring parental intervention throughout the night. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Bedtime routine, Sleep schedule and Intervention (bedtime)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 10 Apr 2019
- 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 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant has disruptive night wakings (wakes 1x or more/night, 5+ nights per wk; caregiver intervenes at night wakings)
- Infant is placed in bed asleep in a crib/bassinet or similar at bedtime at least five nights per week
- Parent/caregiver goal is for the infant to fall asleep independently at bedtime and/or return to sleep independently during the night
- Parent/caregiver goal is for the infant to sleep in crib or similar
- Parent/caregiver lives in the home with the infant, is typically at home at the time of the infant's typical bedtime at least 5 nights a week, and is primary caregiver at bedtime and during the night.
- The family must have in-home private wireless access that they are willing to share with the study team (necessary for streaming video)
- Families lives in Indianapolis, Indiana or surrounding areas (within 50 miles of Indiana University School of Medicine)
Who cannot join
- Infant has a chronic major medical condition that affects sleep
- Infant has a major developmental condition (e.g. Down syndrome)
- Family is already receiving professional help for the infant's sleep problems
- Infant snores 5+ nights per week (in which case a sleep study will be recommended; families could participate in the study following a negative sleep study.)
- Infant has chronic skin conditions (e.g. eczema) that would prohibit wearing an actigraph on the leg
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Infant Behavioral Sleep Intervention: Comparative Efficacy Across Two Approaches "The Sleeping Baby Study"
While frequent night awakenings in newborns are common and expected, an estimated 20-30% of older infants and toddlers have frequent problematic night wakings requiring parental intervention throughout the night. Standard infant behavioral sleep intervention approaches, which require parental intervention throughout the night, are effective but often difficult for families to implement. The aim of this study is to compare the efficacy of two infant behavioral sleep interventions with a no treatment condition, on infant sleep and family functioning. Healthy infants between the ages of 6 and 18 months with night wakings will be randomized into one of three conditions: Entire night intervention, bedtime only intervention, or no treatment.
Read the detailed description
Study Design: Randomized controlled trial (RCT). Approximately thirty participants will be randomized to a control condition or one of two intervention conditions.
Participants: Participants are healthy infants between the ages of 6 and 18 months who wake during the night, and their parents. Parents must be willing to engage in infant behavioral sleep intervention.
Study Procedure: Participant recruitment strategies include direct referrals from community primary care providers (PCP)s, signs posted in medical offices, and social media posts. Participants will be screened and consented via phone. Team members will conduct three home visits with participating families to install videorecording device and actigraphy and take a sleep history (Visit 1); teach families the intervention (Visit 2); and remove monitoring equipment and offer intervention to families in the control condition (Visit 3). Parents will be asked to complete daily sleep logs and three sets of surveys using REDCap.
Intervention: The intervention consists of an infant behavioral sleep protocol. For both intervention conditions an interventionist will collaborate with the family to design a tailored sleep schedule and bedtime routine. The interventionist will then teach the family a behavioral approach, which involves placing the infant in his/her crib awake, and leaving the room. The behavioral approach will be individually tailored for each family (e.g., periodic checks). The two intervention conditions differ in regards to the timing of the intervention. In the all night condition, which represents a standard intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings. In the bedtime only condition, parents are asked to implement the behavioral protocol at bedtime only, and to soothe their infant back to sleep following night wakings.
Measures: Infant sleep will be assessed via parent-report (sleep diary and validated measure); actigraphy; and videosomnography. Parent sleep, parent mood, and infant mood will be assessed via validated parental-report survey measures.
Collaborators on this study include: AJ Schwichtenberg, Purdue University; Jodi Mindell, Saint Joseph University.
- Conditions
- Insomnia
- Being tested
- Bedtime routine, Sleep schedule, Intervention (bedtime), Intervention (after night wakings)
- Keywords
- Infant behavioral sleep intervention, Infant sleep, Pediatric insomnia, Infant night wakings
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedtime routineBehavioural
Tailored bedtime routine
Sleep scheduleBehavioural
Tailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime.
Intervention (bedtime)Behavioural
Parents implement behavioral sleep intervention at bedtime.
Intervention (after night wakings)Behavioural
Parents implement behavioral sleep intervention following each night waking.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Infant sleep monitoring and parental surveys only |
| Intervention (Bedtime only) | Experimental | Infant behavioral sleep intervention implemented at bedtime only. Parents are instructed to soothe/help their infant back to sleep after night wakings. Includes a tailored sleep schedule and bedtime routine, as well as support from a sleep interventionist. Receives: Behavioral: Bedtime routine; Behavioral: Sleep schedule; Behavioral: Intervention (bedtime) |
| Intervention (All night) | Experimental | Infant behavioral sleep intervention implemented at bedtime and after each subsequent infant night waking. Includes a tailored sleep schedule and bedtime routine, as well as support from a sleep interventionist. Receives: Behavioral: Bedtime routine; Behavioral: Sleep schedule; Behavioral: Intervention (bedtime); Behavioral: Intervention (after night wakings) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant sleep (subjective)
Total score on Infant Sleep Questionnaire (ISQ; range=0-38; higher score indicate more problematic sleep)
Measured: Change in score from baseline (day 2, prior to the start of intervention) to post-intervention (day 16)
Secondary outcomes (7)
Infant sleep (objective): wake after sleep onset
Wake after sleep onset in minutes (assessed via videosomnography)
Measured: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Infant sleep (subjective): wake after sleep onset
Wake after sleep onset in minutes (assessed via parent report on sleep diary)
Measured: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Infant sleep (objective): longest sleep period
Longest sleep period in minutes (assessed via videosomnography)
Measured: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Infant sleep (subjective): longest sleep period
Longest sleep period in minutes (assessed via parent report on sleep diary)
Measured: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Parental stress
Daily parental rating of nightly stress associated with their infant's sleep
Measured: Average from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Parental mood
Profile of Mood State - 2nd edition, total score
Measured: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
Parental sleep
Pittsburgh Sleep Quality Index, total score
Measured: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Feb 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Families are randomly assigned to one of three groups: control, bedtime only (intervention), or all night (intervention).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, Saint-Joseph University
- Responsible party
- Principal investigator, Sarah Honaker, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447665
- Sponsor's protocol ID
- VFR-43-Honaker
- Status last verified
- Apr 2019
- First submitted
- 9 Feb 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Behavioral Sleep Intervention: Comparative Efficacy Across Two Approaches "The Sleeping Baby Study"
- ClinicalTrials.gov ID
- NCT03447665
- Acronym / sponsor ID
- VFR-43-Honaker
- Conditions
- Insomnia
- Keywords
- Infant behavioral sleep intervention, Infant sleep, Pediatric insomnia, Infant night wakings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, Saint-Joseph University
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 27 Feb 2018 (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.
While frequent night awakenings in newborns are common and expected, an estimated 20-30% of older infants and toddlers have frequent problematic night wakings requiring parental intervention throughout the night. Standard infant behavioral sleep intervention approaches, which require parental intervention throughout the night, are effective but often difficult for families to implement. The aim of this study is to compare the efficacy of two infant behavioral sleep interventions with a no treatment condition, on infant sleep and family functioning. Healthy infants between the ages of 6 and 18 months with night wakings will be randomized into one of three conditions: Entire night intervention, bedtime only intervention, or no treatment.
Detailed description
Study Design: Randomized controlled trial (RCT). Approximately thirty participants will be randomized to a control condition or one of two intervention conditions.
Participants: Participants are healthy infants between the ages of 6 and 18 months who wake during the night, and their parents. Parents must be willing to engage in infant behavioral sleep intervention.
Study Procedure: Participant recruitment strategies include direct referrals from community primary care providers (PCP)s, signs posted in medical offices, and social media posts. Participants will be screened and consented via phone. Team members will conduct three home visits with participating families to install videorecording device and actigraphy and take a sleep history (Visit 1); teach families the intervention (Visit 2); and remove monitoring equipment and offer intervention to families in the control condition (Visit 3). Parents will be asked to complete daily sleep logs and three sets of surveys using REDCap.
Intervention: The intervention consists of an infant behavioral sleep protocol. For both intervention conditions an interventionist will collaborate with the family to design a tailored sleep schedule and bedtime routine. The interventionist will then teach the family a behavioral approach, which involves placing the infant in his/her crib awake, and leaving the room. The behavioral approach will be individually tailored for each family (e.g., periodic checks). The two intervention conditions differ in regards to the timing of the intervention. In the all night condition, which represents a standard intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings. In the bedtime only condition, parents are asked to implement the behavioral protocol at bedtime only, and to soothe their infant back to sleep following night wakings.
Measures: Infant sleep will be assessed via parent-report (sleep diary and validated measure); actigraphy; and videosomnography. Parent sleep, parent mood, and infant mood will be assessed via validated parental-report survey measures.
Collaborators on this study include: AJ Schwichtenberg, Purdue University; Jodi Mindell, Saint Joseph University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Families are randomly assigned to one of three groups: control, bedtime only (intervention), or all night (intervention).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Infant sleep monitoring and parental surveys only |
| Intervention (Bedtime only) | Experimental | Behavioral: Bedtime routine, Behavioral: Sleep schedule, Behavioral: Intervention (bedtime)Infant behavioral sleep intervention implemented at bedtime only. Parents are instructed to soothe/help their infant back to sleep after night wakings. Includes a tailored sleep schedule and bedtime routine, as well as support from a sleep interventionist. |
| Intervention (All night) | Experimental | Behavioral: Bedtime routine, Behavioral: Sleep schedule, Behavioral: Intervention (bedtime), Behavioral: Intervention (after night wakings)Infant behavioral sleep intervention implemented at bedtime and after each subsequent infant night waking. Includes a tailored sleep schedule and bedtime routine, as well as support from a sleep interventionist. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infant has disruptive night wakings (wakes 1x or more/night, 5+ nights per wk; caregiver intervenes at night wakings)
- Infant is placed in bed asleep in a crib/bassinet or similar at bedtime at least five nights per week
- Parent/caregiver goal is for the infant to fall asleep independently at bedtime and/or return to sleep independently during the night
- Parent/caregiver goal is for the infant to sleep in crib or similar
- Parent/caregiver lives in the home with the infant, is typically at home at the time of the infant's typical bedtime at least 5 nights a week, and is primary caregiver at bedtime and during the night.
Key exclusion criteria (5 listed)
- Infant has a chronic major medical condition that affects sleep
- Infant has a major developmental condition (e.g. Down syndrome)
- Family is already receiving professional help for the infant's sleep problems
- Infant snores 5+ nights per week (in which case a sleep study will be recommended; families could participate in the study following a negative sleep study.)
- Infant has chronic skin conditions (e.g. eczema) that would prohibit wearing an actigraph on the leg
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 |
|---|---|---|
| Bedtime routineTailored bedtime routine | Behavioural | Intervention (All night), Intervention (Bedtime only) |
| Sleep scheduleTailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime. | Behavioural | Intervention (All night), Intervention (Bedtime only) |
| Intervention (bedtime)Parents implement behavioral sleep intervention at bedtime. | Behavioural | Intervention (All night), Intervention (Bedtime only) |
| Intervention (after night wakings)Parents implement behavioral sleep intervention following each night waking. | Behavioural | Intervention (All night) |
Primary outcome
Infant sleep (subjective)
Time frame: Change in score from baseline (day 2, prior to the start of intervention) to post-intervention (day 16)
Total score on Infant Sleep Questionnaire (ISQ; range=0-38; higher score indicate more problematic sleep)
7 secondary outcomes
Infant sleep (objective): wake after sleep onset
Time frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Infant sleep (subjective): wake after sleep onset
Time frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Infant sleep (objective): longest sleep period
Time frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Infant sleep (subjective): longest sleep period
Time frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Parental stress
Time frame: Average from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Parental mood
Time frame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
Parental sleep
Time frame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
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 18 Apr 2019.
- 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.
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 Bedtime routine, Sleep schedule and Intervention (bedtime) in people with Insomnia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 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 18 Apr 2019. 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?
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 sleep (subjective) (time frame: Change in score from baseline (day 2, prior to the start of intervention) to post-intervention (day 16)). 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 18 Apr 2019.