Sleep Characteristics in Infants With Joint Hypermobility
Investigation of Sleep Characteristics in Infants With Joint Hypermobility
1 other identifier
observational
60
1 country
1
Brief Summary
Joint hypermobility is defined as an increased range of motion in one or more joints compared to the normal range. The Beighton Scoring (BS) system is commonly used to distinguish individuals with generalized joint hypermobility from those without. Passive joint range of motion varies among infants, children, and adults. Since younger children exhibit greater joint mobility than older children and adults, age-specific revisions of the cut-off values are necessary for the diagnosis of Generalized Joint Hypermobility (GJH). To this end, a recent study suggested that children aged 12 to 60 months should be diagnosed with GJH if the BS is greater than 4. Studies have shown that motor development in children with joint hypermobility is delayed during early childhood, although most children catch up with their peers before the age of two. Infants with joint hypermobility experience significant delays in both gross and fine motor development. Additionally, proprioceptive impairments have been identified in both children and adults with joint hypermobility. A study evaluating sensory processing skills in toddlers with GJH reported sensory processing difficulties compared to their non-GJH peers. A review of the literature reveals that GJH affects the musculoskeletal system, motor development, and sensory processing skills in infants; however, no studies have been found investigating sleep characteristics in infants with GJH. This study aims to investigate the sleep characteristics of term infants aged 6 to 9 months with GJH and to compare them with their non-GJH peers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
August 13, 2025
CompletedStudy Start
First participant enrolled
August 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2025
CompletedFebruary 12, 2026
September 1, 2025
3 months
August 6, 2025
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Infant Sleep Questionnaire
The Brief Infant Sleep Questionnaire (BISQ) will be used to assess sleep. This questionnaire has been translated into Turkish and assesses the sleep environment and sleep problems in infants. It consists of 33 items and is based on parental reports of infant or toddler sleep patterns, which are used to validate the data.The BISQ is a questionnaire that measures the following parameters: Average nighttime sleep duration (hours) Average daytime sleep duration (hours) Average total 24-hour sleep duration (hours) Number of nighttime awakenings Nighttime awake time (minutes) Time it takes to fall asleep Parent perceptions about sleep (e.g., are there any sleep problems?) Comparisons are generally made based on duration and numbers. For example, is the average nightly sleep duration of Group A significantly longer than Group B? Or is the number of nightly awakenings inversely proportional to total sleep duration?
6 months
Study Arms (2)
Joint hypermobility
Joint hypermobility is defined as an increased range of motion in one or more joints compared to the normal range. The Beighton Scoring system is commonly used to distinguish individuals with generalized joint hypermobility from those without. The Beighton Score system includes the following assessments: passive dorsiflexion of the fifth metacarpophalangeal joint, passive hyperextension of the elbow, passive hyperextension of the knee, passive apposition of the thumb to the flexor aspect of the forearm, and forward flexion of the trunk. Infants aged 6-9 months with a Beighton Score \> 4 will be included in the joint hypermobility group.
Healthy infants
A control group consisting of healthy infants, born at term and 6-9-month-old infants without joint hypermobility
Interventions
The Beighton Scoring system is commonly used to distinguish individuals with generalized joint hypermobility from those without. The Beighton Scoring system includes the following assessments: passive dorsiflexion of the fifth metacarpophalangeal joint, passive hyperextension of the elbow, passive hyperextension of the knee, passive apposition of the thumb to the flexor aspect of the forearm, and forward flexion of the trunk. A Developmental Physiotherapy and Pediatric Rehabilitation specialist will evaluate the joint hypermobility assessment of infants.
Infant sleep problems are among the most common problems presented to pediatricians. The extended version of the "Brief Infant Sleep Questionnaire" is a questionnaire developed by Sadeh to assess sleep problems and their causes in early childhood.
Eligibility Criteria
Joint hypermobility is defined as an increased range of motion in one or more joints compared to the normal range.While sleep problems can negatively impact an individual's life at any age, their risk for children with joint hypermobility has not been investigated. Therefore, this study aims to address this gap in the literature by evaluating sleep characteristics in children with Joint hypermobility. Infants aged 6-9 months with a Beighton Score \> 4 will be included in the joint hypermobility group.A control group consisting of healthy infants, born at term and 6-9-month-old infants without joint hypermobility
You may qualify if:
- Term infants
- Infants with joint hypermobility
- Post-term infants between 6 and 9 months old
You may not qualify if:
- Premature infants
- Infants with congenital malformations
- Infants diagnosed with metabolic, neurological, or genetic diseases
- Infants with joint hypermobility due to any musculoskeletal disease
- Children whose parents did not volunteer for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nigde Omer Halisdemir University
Niğde, Turkey (Türkiye)
Related Publications (4)
Sedky K, Gaisl T, Bennett DS. Prevalence of Obstructive Sleep Apnea in Joint Hypermobility Syndrome: A Systematic Review and Meta-Analysis. J Clin Sleep Med. 2019 Feb 15;15(2):293-299. doi: 10.5664/jcsm.7636.
PMID: 30736885RESULTBoran, P., et al., Translation into Turkish of the expanded version of the "Brief Infant Sleep Questionnaire" and its application to infants. Marmara Medical Journal, 2014. 27(3): p. 178-183.
RESULTSadeh A. A brief screening questionnaire for infant sleep problems: validation and findings for an Internet sample. Pediatrics. 2004 Jun;113(6):e570-7. doi: 10.1542/peds.113.6.e570.
PMID: 15173539RESULTYildiz A, Yildiz R, Burak M, Zorlular R, Akkaya KU, Elbasan B. An investigation of sensory processing skills in toddlers with joint hypermobility. Early Hum Dev. 2024 May;192:105997. doi: 10.1016/j.earlhumdev.2024.105997. Epub 2024 Apr 2.
PMID: 38614033RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rabia ZORLULAR
Nigde Omer Halisdemir University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 6, 2025
First Posted
August 13, 2025
Study Start
August 15, 2025
Primary Completion
November 15, 2025
Study Completion
November 15, 2025
Last Updated
February 12, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share