Insomnia Chronic
Conditions
Brief summary
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.
Interventions
DEVICESleep sensor technology
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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
1. Age between 2-12 months. 2. Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.
Exclusion criteria
1. Diagnosed comorbid health problem that may disrupt sleep. 2. History of birth prior to 37 weeks gestational age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary | Baseline to 5 days post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score | Baseline to post-intervention (approximately 20 days) | 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. |
| Change in Caregiver Epworth Sleepiness Scale (ESS) | Baseline to post-intervention (approximately 20 days) | 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. |
| Change in Patient Health Questionnaire-2 (PHQ-2) Score | Baseline to post-intervention (approximately 20 days) | A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Duke Pediatric outpatient clinics from October 2021 to June 2022.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Sleep Device Intervention |
|---|---|
| Age, Continuous | 6.2 months STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: Baseline to 5 days post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Device Intervention | Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary | -0.88 awakenings per night | Standard Deviation 0.89 |
p-value: 0.000393t-test, 2 sided
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.
Time frame: Baseline to post-intervention (approximately 20 days)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Device Intervention | Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score | 13.4 score on a scale | Standard Deviation 10.6 |
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.
Time frame: Baseline to post-intervention (approximately 20 days)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Device Intervention | Change in Caregiver Epworth Sleepiness Scale (ESS) | -0.94 score on a scale | Standard Deviation 2.95 |
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.
Time frame: Baseline to post-intervention (approximately 20 days)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Device Intervention | Change in Patient Health Questionnaire-2 (PHQ-2) Score | -0.47 score on a scale | Standard Deviation 1.16 |