Clinical trials: Infant Sleep Problems, open to volunteers
Cystic Fibrosis (CF), Fatigue
CF Wellness Program
This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) Intervention Adherence (completion of the CFWP Coaching Sessions) (2) Study…
- Conditions
- Cystic Fibrosis (CF), Fatigue, Sleep Quality, Insomnia
- Trial name
- NCT07071324
- Testing
- CF Wellness Program
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Johns Hopkins University
Insomnia
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
- Trial name
- NCT06498128
- Testing
- Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication
- Where
- 7 sites in United States, Canada and 5 more
- Volunteers
- 785 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals.
- Trial name
- OMF21 (NCT07195253)
- Testing
- Polysomnography (PSG) to explore OSA, Oro-myo-functional clinical evaluation, Sleep Disturbance Scale for Children
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Infant Sleep Problems, Circadian Rhythm
Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
- Conditions
- Infant Sleep Problems, Circadian Rhythm, Neurodevelopment
- Trial name
- NCT07533578
- Testing
- Chronobiologically Timed Feeding of Expressed Breast Milk, Usual Feeding Practice (Untimed Expressed Breast Milk)
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Luzerner Kantonsspital
Postpartum Depression, Postpartum Anxiety
Improving Maternal Sleep and Mental Health
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep.
- Conditions
- Postpartum Depression, Postpartum Anxiety, Sleep Disturbance, Infant Behavior
- Trial name
- SHINE (NCT06544941)
- Testing
- Smart Bassinet, HALO
- Where
- United States
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Colorado Springs
Insomnia
Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants
Behavioral insomnia of childhood affects 15-30% of infants. Behavioral interventions, based on limiting parent-child bedtime and nighttime interactions, are effective in significantly improving infant sleep problems.
- Trial name
- NCT05726890
- Testing
- bedtime intervention for early childhood insomnia, bedtime and nighttime intervention for early childhood insomnia
- Where
- Israel
- Volunteers
- 270 people
- Sponsor
- Ben-Gurion University of the Negev
Behavioral Insomnia of Childhood
Development of Sleep Intervention for Parent and Child
This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.
- Trial name
- NCT05806450
- Testing
- Intervention, Active control condition
- Where
- South Korea
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Sungshin Women's University
Sleep Apnea Syndromes in Children, Obesity in Children
Overview: Use of Respiratory Support At Home in Children
the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view
- Conditions
- Sleep Apnea Syndromes in Children, Obesity in Children, Bronchopulmonary Dysplasia (BPD), Neuromuscular Disease
- Trial name
- ELIPSE (NCT06692660)
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Grenoble
Delirium - Postoperative, Sleep Problems
Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants…
- Conditions
- Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
- Trial name
- NCT06861998
- Testing
- Message-based bedtime routine, sleep hygiene education
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Yan Fuxia
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose…
- Conditions
- Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension
- Trial name
- POPS or POP02 (NCT04278404)
- Testing
- The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Duke University
Apnoea, Prematurity
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
The aim of this study is to monitor the frequency of apnoeas (pauses in breathing) on various methods of non-invasive respiratory support that are detected by an automated machine-learning (ML) model based on diaphragmatic…
- Trial name
- NCT07794007
- Testing
- Diaphragmatic electromyography
- Volunteers
- 30 people
- Sponsor
- King's College Hospital NHS Trust
Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome
Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals.
- Trial name
- TET21 (NCT07658053)
- Testing
- CURAPROX pacifier use, Pacifier diary, Polysomnography (PSG) to explore OSA
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Hospices Civils de Lyon
Osteopathy, PreTerm Neonate
The Effect of Cranial Osteopathy Intervention in Preterm Babies
There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated.
- Conditions
- Osteopathy, PreTerm Neonate, Sensory Profiles, Colic
- Trial name
- NCT06967870
- Testing
- Osteopathic intervention, Home based exercise education
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann
Sleep Quality
Infant Swing and Sleep-Wake Cycles
This study was planned to determine the effects of automatic baby swing application on the sleep-wake cycle, comfort behaviors and physiological parameters of babies in the neonatal intensive care unit.
- Trial name
- AISS (NCT07284303)
- Testing
- Care: Automatic Baby Swing
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kirsehir Ahi Evran Universitesi
Sleep, Psychological Distress
The Development and Evaluation of Sleep Intervention for Perinatal Family
Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes.
- Conditions
- Sleep, Psychological Distress, Perinatal Problems
- Trial name
- NCT06487650
- Testing
- sleep intervention, Control group
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University
Sleep Deprivation
The Function of Biphasic Sleep in Infants
This study is designed to investigate developmental changes in naps and nap function on memory from 9 to 15 months of age. Memory is measured by a task in which the experimenter interacts with a toy and the measure of memory is…
- Trial name
- NCT06399939
- Testing
- Nap, Wake
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Amherst
Premature Infants, Sleep Quality
The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants
This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU)…
- Conditions
- Premature Infants, Sleep Quality, İnfant Stress, İnfant Comfort
- Trial name
- NCT07322731
- Testing
- Infant Massage Therapy
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Yuzuncu Yil University
Premature Birth, Asthma in Children
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Despite improved survival of extremely premature infants in recent decades, neonatal intensive care unit (NICU) graduates are diagnosed with asthma, sleep disordered breathing (SDB) in childhood, and neurodevelopmental…
- Conditions
- Premature Birth, Asthma in Children, Sleep-Disordered Breathing, Neurodevelopmental Disorders
- Trial name
- NCT05336890
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Infant Sleep Problem
Smart Baby Monitor Effects on Infant Sleep and Parent Well-being
The goal of this clinical trial is to learn whether a smart baby monitor with full sleep analytics and behavioral guidance improves infant sleep and parent well-being in first-time parents during the first six months after birth.
- Trial name
- NCT07812896
- Testing
- Smart Baby Monitor with Sleep Analytics and Behavioral Guidance, Smart Baby Monitor with Live Video Only
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Udisense DBA Nanit