Infant Sleep ProblemsNCT03640533
The Efficacy of the Nanit-Insights App in Improving Infant Sleep
A study testing Nanit-Insights in people with Infant Sleep Problems, run by Tel Aviv University at 1 site in United States.
Trial summary
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep. Read more about this study
- Who is it for?
- Ages 5 to 7 months
- Conditions the study is for
- Infant Sleep Problems
- What is being tested?
- Nanit-Insights
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2018to 30 Jan 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 7 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant aged 5-7 months
- Presence of a moderate to severe sleep problem at baseline
- Sleeping arrangement in which the infant sleeps in a crib at night
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of the Nanit-Insights App in Improving Infant Sleep: A Randomized Controlled Trial
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep.
Read the detailed description
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep. The intervention provides parents with daily sleep metrics as well as personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data.
Participants will be parents of 5-7 month-old infants, randomized into one of two groups: (1) the intervention group, which will include users who have purchased the baby monitor without subscribing to Nanit Insights and are then offered a six month subscription to Nanit-Insights when their baby is 5-7 months of age; and (2) the control group, which will include users of the baby monitor, who have not subscribed to Nanit-Insights.
Each group will include approximately 150 families.
Sleep will be assessed at baseline and 3- and 6-months following the beginning of the intervention. Computer vision technology will be used to assess infant sleep, as well as parental adherence to the intervention, allowing us to determine whether adherence mediates sleep benefits.
The results of this study are expected to evaluate the effectiveness of a low-cost, app-based intervention for infant sleep problems. Furthermore, the results may broaden the understanding of the mediating role of parent adherence in such interventions.
- Conditions
- Infant Sleep Problems
- Being tested
- Nanit-Insights
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanit-InsightsBehavioural
Nanit-Insights is an app-based intervention that provides personalized sleep tips to parents.
| Study group | Role | What they receive |
|---|---|---|
| Nanit-Insights intervention group | Experimental | Nanit-Insights is an app-based intervention that provides parents with personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data. Receives: Behavioral: Nanit-Insights |
| Nanit-monitor control group | No intervention | Participants in the control group will be given the same monitoring device, that will serve in this group as a baby-monitor only, without providing sleep recommendations to parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in parent-reported infant sleep quality at 3 and 6 months follow-up as assessed using the Extended Brief Infant Sleep Questionnaire
Change from baseline in parent-reported sleep quality at 3 and 6 months follow-up using the Extended Brief Infant Sleep Questionnaire. Items in this questionnaire are either open-ended or reported on a 5-point scale, with 1=poor sleep quality and 5=very good sleep quality.
Measured: Infant sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant sleep efficacy at 3 and 6 months follow-up: Videosomnography
Change from baseline in videosomnography metric of sleep efficacy at 3 and 6 months follow-up. infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. Sleep efficacy will be provided using the algorithm.
Measured: Infant sleep efficacy will be assessed at baseline, and at 3- and 6-month follow-ups.
Secondary outcomes (7)
Change from baseline in parent sleep quality as assessed using the Pittsburgh Sleep Quality Index at 3 and 6 month follow ups.
Change from baseline in parent-reported sleep quality using the Pittsburgh Sleep Quality Index (PSQI) at 3 and 6 month follow ups. The PSQI is comprised of 10 questions, from which the following subscales are generated: sleep latency, sleep duration, sleep disturbances, and daytime-dysfunction. Items are open-ended or rated on a 4-point scale, and higher scores represent poorer sleep.
Measured: Parent sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in parent mood as assessed using the Clinically Useful Depression Outcome Scale at 3 and 6 month follow ups.
Change from baseline in parent-reported mood using the Clinically Useful Depression Outcome Scale (CUDOS) at 3 and 6 month follow ups. Each of the 18 items in the CUDOS is rated on a 5-point scale, with higher ratings indicating poorer mood. Ratings on all items are summed to create a total score.
Measured: Parent mood will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant sleep onset latency at 3 and 6 months follow-up: Videosomnography
Change from baseline in videosomnography metric of sleep onset latency at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm.
Measured: Infant sleep onset latency will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant sleep duration at 3 and 6 months follow-up: Videosomnography
Change from baseline in videosomnography metric of sleep duration at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm.
Measured: Infant sleep duration will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant number of night-wakings at 3 and 6 months follow-up: Videosomnography
Change from baseline in videosomnography metric of number of night-wakings at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm.
Measured: Infant number of night-wakings will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant time out of bed at 3 and 6 months follow-up: Videosomnography
Change from baseline in videosomnography metric of number of time out of bed at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm.
Measured: Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in parental "nightly visits" at 3 and 6 months follow-up: Videosomnography
Change from baseline in videosomnography metric of parental "nightly visits" to the crib at 3 and 6 months follow-up. Parental visits to the infant in the crib will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm.
Measured: Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start6 Sep 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2021
Why it stopped: Technical probelms led to inadequate randomization, and thus the project was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Sleep ProblemsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders University, UdiSense Inc.
- Responsible party
- Principal investigator, Michal Kahn, Tel Aviv University
- Investigators
- Michal Kahn, PhD, Study director, Tel Aviv UniversityMichael Gradisar, PhD, Principal investigator, Flinders University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640533
- Sponsor's protocol ID
- Insights
- Status last verified
- Mar 2021
- First submitted
- 15 Aug 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be encrypted, to ensure privacy of participants. It will be shared with investigators of the present study only.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Nanit-Insights App in Improving Infant Sleep: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03640533
- Acronym / sponsor ID
- Insights
- Conditions
- Infant Sleep Problems
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical probelms led to inadequate randomization, and thus the project was terminated.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Flinders University, UdiSense Inc.
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 21 Aug 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.
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep.
Detailed description
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep. The intervention provides parents with daily sleep metrics as well as personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data.
Participants will be parents of 5-7 month-old infants, randomized into one of two groups: (1) the intervention group, which will include users who have purchased the baby monitor without subscribing to Nanit Insights and are then offered a six month subscription to Nanit-Insights when their baby is 5-7 months of age; and (2) the control group, which will include users of the baby monitor, who have not subscribed to Nanit-Insights.
Each group will include approximately 150 families.
Sleep will be assessed at baseline and 3- and 6-months following the beginning of the intervention. Computer vision technology will be used to assess infant sleep, as well as parental adherence to the intervention, allowing us to determine whether adherence mediates sleep benefits.
The results of this study are expected to evaluate the effectiveness of a low-cost, app-based intervention for infant sleep problems. Furthermore, the results may broaden the understanding of the mediating role of parent adherence in such interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanit-Insights intervention group | Experimental | Behavioral: Nanit-InsightsNanit-Insights is an app-based intervention that provides parents with personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data. |
| Nanit-monitor control group | No intervention | –Participants in the control group will be given the same monitoring device, that will serve in this group as a baby-monitor only, without providing sleep recommendations to parents. |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant aged 5-7 months
- Presence of a moderate to severe sleep problem at baseline
- Sleeping arrangement in which the infant sleeps in a crib at night
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Nanit-InsightsNanit-Insights is an app-based intervention that provides personalized sleep tips to parents. | Behavioural | Nanit-Insights intervention group |
Primary outcome
Change from baseline in parent-reported infant sleep quality at 3 and 6 months follow-up as assessed using the Extended Brief Infant Sleep Questionnaire
Time frame: Infant sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in parent-reported sleep quality at 3 and 6 months follow-up using the Extended Brief Infant Sleep Questionnaire. Items in this questionnaire are either open-ended or reported on a 5-point scale, with 1=poor sleep quality and 5=very good sleep quality.
Change from baseline in infant sleep efficacy at 3 and 6 months follow-up: Videosomnography
Time frame: Infant sleep efficacy will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in videosomnography metric of sleep efficacy at 3 and 6 months follow-up. infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. Sleep efficacy will be provided using the algorithm.
7 secondary outcomes
Change from baseline in parent sleep quality as assessed using the Pittsburgh Sleep Quality Index at 3 and 6 month follow ups.
Time frame: Parent sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in parent mood as assessed using the Clinically Useful Depression Outcome Scale at 3 and 6 month follow ups.
Time frame: Parent mood will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant sleep onset latency at 3 and 6 months follow-up: Videosomnography
Time frame: Infant sleep onset latency will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant sleep duration at 3 and 6 months follow-up: Videosomnography
Time frame: Infant sleep duration will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant number of night-wakings at 3 and 6 months follow-up: Videosomnography
Time frame: Infant number of night-wakings will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in infant time out of bed at 3 and 6 months follow-up: Videosomnography
Time frame: Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in parental "nightly visits" at 3 and 6 months follow-up: Videosomnography
Time frame: Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.
Results and safety
The study was stopped early (reason given: Technical probelms led to inadequate randomization, and thus the project was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No. IPD will be encrypted, to ensure privacy of participants. It will be shared with investigators of the present study only.
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Infant Sleep Problem
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.
Michal Kahn, PhD study director
Tel Aviv University
Michael Gradisar, PhD principal investigator
Flinders University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanit-Insights in people with Infant Sleep Problems, run by Tel Aviv 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Apr 2021. 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 was stopped early (reason given: Technical probelms led to inadequate randomization, and thus the project was terminated.). Results are not available in the source record.
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?
Change from baseline in parent-reported infant sleep quality at 3 and 6 months follow-up as assessed using the Extended Brief Infant Sleep Questionnaire (time frame: Infant sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.). 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?
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 1 Apr 2021.