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Down SyndromeNCT03267602

Role of Sleep Apnea in the Neuropsychological Function in Down Syndrome People

A study testing CPAP in people with Down Syndrome, run by National Taiwan University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is the first study about Neuropsychological function and OSAS in Taiwan. Although the correlation between OSAS and neuropsychological abnormalities had been reported, it is worth to understand more about the detailed domains that involved in our cohort. Read more about this study

Who is it for?
Any age
Conditions the study is for
Down Syndrome
What is being tested?
CPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Dec 2012to Dec 2016
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosed with Down's syndrome by chromosome test, over 6 years old and IQ> 40.
  • Participants and caregiver who are willing and comply with study.

Who cannot join

  • Known to have uncontrolled heart, stomach, kidney or neurological / psychiatric disorders.
  • Cannot comply with study。

About this study

This is the first study about Neuropsychological function and OSAS in Taiwan. Although the correlation between OSAS and neuropsychological abnormalities had been reported, it is worth to understand more about the detailed domains that involved in our cohort. After this, investigators can dissect the cause of mental retardation in DS and help for further treatment strategies.

Read the detailed description

Down Syndrome (DS) is the most common cause of mental retardation with incidence of 1 in 848 (Lin, Hu et al. 1991). Although prenatal Down syndrome and Amniocentesis had been applied for years, in the survey of 2005, current birth incidence of DS is 1.6 in 10,000 live birth, meaning a 30-50 new cases per year (Jou, Kuo et al. 2005). Patients with DS will have multisystemic manifestations including short stature, mental retardation, dysmorphism, congenital heart disease, congenital anomaly of gastrointestinal and genitourinary tract, abnormal endocrine function, leukemia and leukemoid reaction. Beside mental retardation, other anomalies could be treated or controlled by current medical care. The IQ of DS is around 20-80 with significant cognitive, language, and behavior problems (Dierssen, Ortiz-Abalia et al. 2006).

In addition, obstructive sleep apnea syndrome (OSAS) had been observed in DS people with prevalence about 45-79% in the literature (de Miguel-Diez, Villa-Asensi et al. 2003; Dyken, Lin-Dyken et al. 2003; Shott, Amin et al. 2006; Fitzgerald, Paul et al. 2007), which is much higher than the 1-3% prevalence rate in general population (Holmes 1993; Gislason and Benediktsdottir 1995). The reasons of DS people prone to have OSAS are due to the combination of anatomical and physiological factors. In DS people, facial dysmorphism (midfacial hypoplasia, mandibular hypoplasia), macroglossia, small hypopharynx, pharyngeal hypotonia, tonsil and adenoid enlargement, obesity, laryngomalacia, and tracheomalacia contributed to upper airway obstructions in DS people (Trois, Capone et al. 2009; Pandit and Fitzgerald 2012). In addition, DS people has increased incidence of lower respiratory tract diseases including gastroesophageal reflux, immunological dysfunction, tracheal bronchus, airway malacia, congenital heart disease, and pulmonary hypoplasia, which will predispose to OSAS. While growing up, DS people still have generalized hypotonia with increasing risk of developing hypothyroidism and obesity, which are also risk factors for OSAS (Trois, Capone et al. 2009).

It has been noted that sleep disordered breathing is associated with neurocognitive deficit, particularly of memory, learning, attention, hyperactivity, executive functioning, cognitive capacity, and poor school performance (Beebe 2006; Pandit and Fitzgerald 2012). And a number of studies have reported improved attention, executive functioning, analytical thinking, verbal functioning, memory and academic progress at 6-12 months post- adenotonsillectomy (Chervin, Ruzicka et al. 2006). In DS, study demonstrated that a higher number of apneic episodes on polysomnography was correlated to the decreased visuoperceptual skill in DS (Andreou, Galanopoulou et al. 2002). Similarly, presence of snoring in DS was associated with a much higher rate of disruptive school behavior than without snore (Carskadon, Pueschel et al. 1993). Although learning disability and memory defect had been globally known in DS, the behavior, cognitive, and developmental impairment caused by OSAS is especially concerning because it might adversely affect their ability, even the social adaptation (Rihtman, Tekuzener et al. 2010) . Therefore, investigators would like to know the correlation between severity of OSAS and Neurocognitive and behavior in DS people in Taiwan. Also, investigators would like to follow the Neurocognitive and behavior changes in those who had been treated for OSAS, including tonsillectomy or Bilevel Positive Airway Pressure.

Conditions
Down Syndrome
Being tested
CPAP
Medical subject headings
Down Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAPDevice

    If following patients are suffering from sleep apnea and agree to receive treatment,

    1. older than 18 years, AHI> 15 and present obvious symptoms or
    2. less than 18 years, AHI still> 5 after tonsillectomy and present obvious symptoms.

    Investigators will process CPAP treatment for 3 months, and do neuropsychological assessment and sleep examination after treatment for 6 months.

Study groups in NCT03267602
Study groupRoleWhat they receive
Continuous Positive Airway Pressure (CPAP) TherapyExperimentalNot described
Receives: Device: CPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessed the sleep apnea level with Apnoea-Hypopnoea Index (AHI) score.

    Measured: 3 months

  2. Assessed neuropsychological functions with Wechsler Preschool and Primary Scale of Intelligence (WPPSI-R) vocabulary subdomain score.

    Measured: 3 months

Secondary outcomes (9)
  1. Assessed the memory domain that subtest of Sentence (WPPSI-R) .

    Measured: 3 months

  2. Assessed the memory domain that forward memory (Leiter International Performance Scale-Revised) .

    Measured: 3 months

  3. Evaluation of participants's Visuospatial functions with Geometric Design (WPPSI-R).

    Measured: 3 months

  4. Evaluation of participants's Visuospatial functions with Block Design (WPPSI-R).

    Measured: 3 months

  5. The Executive domain was assessed with TOWER (Developmental NEuroPSYchological Assessment, NEPSY)

    Measured: 3 months

  6. Assessed the Language domain with Vocabulary subtest

    Measured: 3 months

  7. Assessed the Sensorimotor domain with Visuomotor Precision-train and car

    Measured: 3 months

  8. Measurement the effectiveness of therapy before and after treatment with Apnoea-Hypopnoea Index (AHI).

    Measured: 12 months

  9. Measurement the effectiveness of therapy before and after treatment with Oxygen Desaturation Index (ODI).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study startDec 2012
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03267602
Sponsor's protocol ID
201208075RIC
Status last verified
Aug 2017
First submitted
17 Aug 2017
Last updated
5 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CPAP in people with Down Syndrome, run by National Taiwan University Hospital.

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 2 inclusion and 2 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Assessed the sleep apnea level with Apnoea-Hypopnoea Index (AHI) score. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Sep 2017.

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