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NCT05078112 · ClinicalTrials.gov registry record · NA

Sleep Device Testing to Promote Sleep in Infants

A NA study of Insomnia Chronic, sponsored by Duke University.

Completed
Registry status
NA
Development phase
19
Enrollment target
1
Study location

NCT05078112: Completed NA study of Insomnia Chronic, sponsored by Duke University.

NCT05078112 is a NA study of Insomnia Chronic that has completed, run by Duke University. The registered enrollment target is 19 participants, below the 117-participant average among 16 other Insomnia Chronic trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05078112, a NA study of Insomnia Chronic, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
19 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DEVICE Sleep sensor technology

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2021-10-20
Est. Completion 2022-07-31
Phase NA
Duke University

1,725 total trials

What the finished NCT05078112 record still lists

NCT05078112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 117-participant average among 16 other Insomnia Chronic trials with a reported enrollment target (84% lower).

The record links to 1 condition, with Insomnia Chronic appearing as the primary indexed condition, and to 1 intervention - of which Sleep sensor technology is the first listed.

NCT05078112 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT05078112 about?

NCT05078112 is a clinical study titled "Sleep Device Testing to Promote Sleep 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 te...

What is the current status of trial NCT05078112?

This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2021-10-20. Estimated completion is 2022-07-31.

What conditions does trial NCT05078112 study?

This clinical trial studies the following conditions: Insomnia Chronic.

What interventions are being tested in trial NCT05078112?

The interventions under investigation include: Sleep sensor technology (DEVICE).

Who is sponsoring clinical trial NCT05078112?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05078112 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Insomnia Chronic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05078112's enrollment target sits among peer trials

19 16th of 16 higher than 1 of 16 other Insomnia Chronic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Insomnia Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05078112, the US trial registry maintained by the National Library of Medicine. NCT05078112 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.