Joint Hypermobility SyndromeNCT07121179
Sleep Characteristics in Infants With Joint Hypermobility
An observational study of Joint Hypermobility Syndrome and Sleep, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Joint Hypermobility Syndrome, Sleep, Infant
- What is being tested?
- Beighton Scoring system and Brief Infant Sleep Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Term infants
- Infants with joint hypermobility
- Post-term infants between 6 and 9 months old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Sleep Characteristics in Infants With 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 (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.
- Conditions
- Joint Hypermobility Syndrome, Sleep, Infant
- Being tested
- Beighton Scoring system, Brief Infant Sleep Questionnaire
- Keywords
- Joint hypermobility, sleep, infant, development
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beighton Scoring systemBehavioural
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.
Brief Infant Sleep QuestionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Beighton Scoring system; Behavioral: Brief Infant Sleep Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Aug 2025
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Joint Hypermobility SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Nigde Omer Halisdemir University
- Investigators
- Rabia ZORLULAR, Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121179
- Sponsor's protocol ID
- joint hypermobility
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30736885Boran, 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 15173539Yildiz 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sleep Characteristics in Infants With Joint Hypermobility
- ClinicalTrials.gov ID
- NCT07121179
- Acronym / sponsor ID
- joint hypermobility
- Conditions
- Joint Hypermobility Syndrome, Sleep, Infant
- Keywords
- Joint hypermobility, sleep, infant, development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint hypermobility | – | Behavioral: Beighton Scoring system, Behavioral: Brief Infant Sleep QuestionnaireJoint 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 | – | Behavioral: Beighton Scoring system, Behavioral: Brief Infant Sleep QuestionnaireA control group consisting of healthy infants, born at term and 6-9-month-old infants without joint hypermobility |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- Term infants
- Infants with joint hypermobility
- Post-term infants between 6 and 9 months old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beighton Scoring systemThe 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. | Behavioural | Healthy infants, Joint hypermobility |
| Brief Infant Sleep QuestionnaireInfant 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. | Behavioural | Healthy infants, Joint hypermobility |
Primary outcome
Brief Infant Sleep Questionnaire
Time frame: 6 months
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Results publication: PubMed 30736885Sedky 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.
- Results publicationBoran, 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.
- Results publication: PubMed 15173539Sadeh 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.
- Results publication: PubMed 38614033Yildiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia ZORLULAR principal investigator
Nigde Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Hypermobility Syndrome and Sleep, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Infant Sleep Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121179, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.