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Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Device intervention | Experimental | Infants will utilize the sleep device during sleep for 20 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep sensor technology | Device | Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary | Parents reported number of nighttime awakenings on the 5 days immediately prior to intervention (at baseline) and 5 days immediately following the intervention. The intervention takes place during the 20 days in between the measurement of baseline measures and post-intervention measures. The number of nighttime awakenings is averaged over the 5 days prior to intervention and compared to the average over 5 days after intervention. | Baseline to 5 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score | The BISQ-SF is a research tool that measures infant sleep metrics, parental perceptions of the child's sleep, and parental behaviors. The total score is scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sujay Kansagra, MD | Duke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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Participants were recruited from the Duke Pediatric outpatient clinics from October 2021 to June 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Device Intervention | Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Device Intervention | Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary | Parents reported number of nighttime awakenings on the 5 days immediately prior to intervention (at baseline) and 5 days immediately following the intervention. The intervention takes place during the 20 days in between the measurement of baseline measures and post-intervention measures. The number of nighttime awakenings is averaged over the 5 days prior to intervention and compared to the average over 5 days after intervention. | Posted | Mean | Standard Deviation | awakenings per night | Baseline to 5 days post-intervention |
|
Approximately 20 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep Device Intervention | Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sujay Kansagra, MD | Duke University | 919-668-0477 | sujay.kansagra@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2022 | Jul 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Baseline to post-intervention (approximately 20 days) |
| Change in Caregiver Epworth Sleepiness Scale (ESS) | Caregivers evaluate their own sleepiness via the ESS. The ESS has a total score range of 0 to 24, where a higher score indicates greater sleepiness. | Baseline to post-intervention (approximately 20 days) |
| Change in Patient Health Questionnaire-2 (PHQ-2) Score | A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia. | Baseline to post-intervention (approximately 20 days) |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score | The BISQ-SF is a research tool that measures infant sleep metrics, parental perceptions of the child's sleep, and parental behaviors. The total score is scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep. | Caregivers were not considered enrolled, but did contribute to this assessment. Each caregiver that had pre and post-intervention BISQ-SF scores available contributed to this assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post-intervention (approximately 20 days) |
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| Secondary | Change in Caregiver Epworth Sleepiness Scale (ESS) | Caregivers evaluate their own sleepiness via the ESS. The ESS has a total score range of 0 to 24, where a higher score indicates greater sleepiness. | Caregivers were not considered enrolled but did contribute to this assessment. Each caregiver that had pre and post-intervention ESS scores available contributed to this assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post-intervention (approximately 20 days) |
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| Secondary | Change in Patient Health Questionnaire-2 (PHQ-2) Score | A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia. | Caregivers were not considered enrolled but did contribute to this assessment. Each caregiver that had pre and post-intervention PHQ-2 scores available contributed to this assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post-intervention (approximately 20 days) |
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| 0 |
| 19 |
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| 19 |
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| D001523 |
| Mental Disorders |