Clinical trials: Infant Sleep Problems
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
Atopic Dermatitis, Sleep Disturbance
Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation
The SPINDLE study will examine sleep in infants with atopic dermatitis by serial assessment over the first year of life, in comparison to infants without atopic dermatitis.
- Trial name
- SPINDLE (NCT05031754)
- Where
- Ireland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University College Cork
Insomnia Disorder
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
- Trial name
- NCT06393504
- Testing
- Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication
- Where
- United States
- Volunteers
- 2,095 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
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
Insomnia, Night Wakings
Infant Night Wakings in Pediatric Primary Care
This study aims to: 1. identify which single item or combination of two items perform best in identifying problematic infant night wakings and 2.
- Trial name
- NCT02780596
- Testing
- Item1, Item2, Item3
- Where
- United States
- Volunteers
- 3,501 people
- Sponsor
- Indiana University
Apnea of Prematurity, Desaturation of Blood
Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%.
- Conditions
- Apnea of Prematurity, Desaturation of Blood, Central Apnea, Periodic Breathing
- Trial name
- NCT03695900
- Testing
- Targeting SpO2 at 93-95%, Targeting SpO2 at 90-92%
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- University of Miami
Pediatric Sleep Problems, Sleep Hygiene
Storybook App vs Cognitive Behavioral Therapy for Child Sleep and Attachment
This completed randomized controlled trial compared two caregiver-delivered interventions for sleep in young children: a multimodal mobile health intervention delivered through the Storybook mobile application and a face-to-face…
- Conditions
- Pediatric Sleep Problems, Sleep Hygiene, Parent-Child Attachment
- Trial name
- STORYBOOK-RCT (NCT07668609)
- Testing
- CBT-Based Psychoeducational Intervention, Storybook Mobile Application Intervention
- Where
- Ecuador
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidad Católica de Cuenca
Insomnia, Behavioral Insomnia of Childhood
The Validity and Reliability of Brief Infant Sleep Questionnaire Revised (BISQ-R)
Brief Infant Sleep Questionnaire is a frequently used validated tool originally developed by Sadeh for evaluation of behavioral sleep problems in young children. It has been translated into Turkish and found reliable.
- Trial name
- NCT05553171
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Marmara University
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
Cough
Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child.
- Trial name
- NCT01721395
- Testing
- Agave Syrup
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Penn State University
Obstructive Sleep Apnea Syndrome
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant.
- Trial name
- NCT00659854
- Testing
- Non milk or soy based formula, milk based formula
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Soroka University Medical Center
Attachment, Mother-Infant Interaction
The Effect of Affirmation and Massage on Babies
The research was designed as a randomized controlled trial model to examine the effects of affirmation and infant massage taught to the parents of 0-6 month-old infants registered in a Family Health Center and a Private Medical…
- Conditions
- Attachment, Mother-Infant Interaction, Sleep Quality
- Trial name
- NCT05489861
- Testing
- M-AM, F-AM
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
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
Insomnia
Perspectives of Parents About Their Infants' Sleep
Behavioral insomnia of childhood (BIC) is a common problem in early infancy. The whole family is affected by the problem, but research usually relies only on maternal perception and report.
- Trial name
- NCT05092308
- Volunteers
- 60 people
- Sponsor
- Marmara University
Sleep Disturbance in Infancy (Disorder), Neonatal Disease
Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit
The goal of this observational study is to collect data to develop a complete package (hardware, user interface software and algorithms) that can monitor sleep-wake stages in neonates.
- Trial name
- NCT04920175
- Testing
- Novel Real-time Neonatal Sleep Stage Detection Algorithm
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Michigan
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
Cystic Fibrosis
Sleep in Patients With Cystic Fibrosis
The aim of the study is to identify the parameters that are associated with nocturnal hypoventilation in children and adults with cystic fibrosis.
- Trial name
- Sommeil (NCT00804661)
- Testing
- SENTEC device
- Where
- France
- Volunteers
- 76 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris