Insomnia ChronicNCT05078112
Sleep Device Testing to Promote Sleep in Infants
A study testing Sleep sensor technology in people with Insomnia Chronic, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 months
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Sleep sensor technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 2-12 months.
- Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.
Who cannot join
- Diagnosed comorbid health problem that may disrupt sleep.
- History of birth prior to 37 weeks gestational age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants
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.
- Conditions
- Insomnia Chronic
- Being tested
- Sleep sensor technology
- 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.
Sleep sensor technologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Device intervention | Experimental | Infants will utilize the sleep device during sleep for 20 days Receives: Device: Sleep sensor technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 5 days post-intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-intervention (approximately 20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start20 Oct 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujay Kansagra, MD, Principal investigator, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078112
- Sponsor's protocol ID
- Pro00103800
- Status last verified
- Sep 2024
- First submitted
- 4 Oct 2021
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants
- ClinicalTrials.gov ID
- NCT05078112
- Acronym / sponsor ID
- Pro00103800
- Conditions
- Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Device intervention | Experimental | Device: Sleep sensor technologyInfants will utilize the sleep device during sleep for 20 days |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 2-12 months.
- Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.
Key exclusion criteria (2 listed)
- Diagnosed comorbid health problem that may disrupt sleep.
- History of birth prior to 37 weeks gestational age.
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 |
|---|---|---|
| Sleep sensor technologyInfants 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. | Device | Sleep Device intervention |
Primary outcome
Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary
Time frame: 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.
3 secondary outcomes
Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score
Time frame: Baseline to post-intervention (approximately 20 days)
Change in Caregiver Epworth Sleepiness Scale (ESS)
Time frame: Baseline to post-intervention (approximately 20 days)
Change in Patient Health Questionnaire-2 (PHQ-2) Score
Time frame: Baseline to post-intervention (approximately 20 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Insomnia Chronic
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
Chronic Insomnia Disorder
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.
Sujay Kansagra, MD principal investigator
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep sensor technology in people with Insomnia Chronic, run by Duke 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 2 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: finished, as of the sponsor's last update on 15 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary (time frame: Baseline to 5 days post-intervention). 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 15 Oct 2024.