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CompletedNCT07121179Updated Feb 12, 2026

Sleep Characteristics in Infants With Joint Hypermobility

An observational study in Joint Hypermobility Syndrome, Sleep and Infant, sponsored by Nigde Omer Halisdemir University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Months to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Nigde Omer Halisdemir University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
6 Months to 9 Months
Sex
All
01

Study 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.

Read the detailed description

Ligamentous laxity and the resulting joint hypermobility are present in various conditions affecting children, such as Marfan syndrome and Ehlers-Danlos syndrome. However, in most cases, joint hypermobility is a limited condition referred to as Generalized Joint Hypermobility (GJH). GJH is defined as asymptomatic hypermobility in more than five joints. The Beighton Scoring (BS) system is commonly used to distinguish individuals with generalized joint hypermobility from those without. The BS 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.

In children older than five years, a cut-off score of ≥6 is used to diagnose GJH. In adults up to 50 years of age, a score of ≥5 out of 9 indicates GJH, while a score of ≥4 out of 9 is considered positive for GJH in adults over 50 years.

Joint hypermobility can cause stability issues in the musculoskeletal system due to connective tissue laxity. This can trigger problems such as discomfort, restlessness, and difficulty finding a position, especially during sleep. Sleep disruptions due to nighttime restlessness or frequent position changes may also occur. Furthermore, most studies on joint hypermobility in the literature primarily involve adults. Early developmental assessments are crucial for preventing developmental delays that may emerge later in life.

02

Conditions studied

  • Joint Hypermobility Syndrome
  • Sleep
  • Infant

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Keywords

  • Joint hypermobility
  • sleep
  • infant
  • development
03

In context

Joint Instability

115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 54 observational studies indexed under Joint Instability.

Browse Joint Instability studies →

Lead sponsor

Nigde Omer Halisdemir University is the lead sponsor of 93 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 9 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Term infants
  • Infants with joint hypermobility
  • Post-term infants between 6 and 9 months old

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Behavioral: Beighton Scoring system · Behavioral: Brief Infant Sleep Questionnaire

  • Healthy infants

    A control group consisting of healthy infants, born at term and 6-9-month-old infants without joint hypermobility

    Behavioral: Beighton Scoring system · Behavioral: Brief Infant Sleep Questionnaire

Interventions

  • BehavioralBeighton Scoring system

    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.

  • BehavioralBrief Infant Sleep Questionnaire

    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.

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What researchers measure

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?

    Time frame: 6 months

07

Study locations

1 site
  • Nigde Omer Halisdemir University
    Niğde, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 30736885 ↗
  • Boran, 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.
  • Sadeh 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. PubMed 15173539 ↗
  • Yildiz 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. PubMed 38614033 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2025 to primary completion in Nov 2025, 3 months.

Of 22 observational studies under Joint Instability, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 35. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2025
First posted
Aug 13, 2025
StartActual
Aug 15, 2025
Primary completionActual
Nov 15, 2025
CompletionActual
Nov 15, 2025
Last update
Feb 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07121179
Lead sponsor
Nigde Omer Halisdemir University
Responsible party
Rabia ZORLULAR (principal investigator, Nigde Omer Halisdemir University) — Principal investigator
First posted
Aug 13, 2025
Start date
Aug 15, 2025
Primary completion
Nov 15, 2025
Completion
Nov 15, 2025
Last update
Feb 12, 2026

Study contacts

Rabia ZORLULAR
principal investigator · Nigde Omer Halisdemir University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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