NCT05078112

Sleep Device Testing to Promote Sleep in Infants

Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia Chronic

Interventions

Type	Name	Description
DEVICE	Sleep 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.

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2021-10-14
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study