Down SyndromeMorpheeNCT00394290
Down Syndrome and Continuous Positive Pressure Therapy
A study testing Continuous Positive Pressure in people with Down Syndrome and Obstructive Sleep Apnea Syndrome, run by Institut Jerome Lejeune at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Down Syndrome, Obstructive Sleep Apnea Syndrome
- What is being tested?
- Continuous Positive Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2006to 31 Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Down Syndrome patients with an Obstructive Sleep Apnea Syndrome
- more than 18 years old
Who cannot join
- predictable non-compliance of device
- non-compensated cardiopathy
- non-stable thyroxin treatment
- non-stable diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.
- Conditions
- Down Syndrome, Obstructive Sleep Apnea Syndrome
- Being tested
- Continuous Positive Pressure
- Keywords
- Down Syndrome, Obstructive Sleep Apnea Syndrome, Continuous Positive Pressure, Hypersomnia
- Medical subject headings
- Down Syndrome, Sleep Apnea, Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive PressureDevice
Nighttime continuous positive pressure device, to be used every day
| Study group | Role | What they receive |
|---|---|---|
| PPC | Experimental | Night time device for positive pulmonary pressure Receives: Device: Continuous Positive Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)
Measured: 0 and 3 months
Secondary outcomes (1)
Tolerability
Measured: 0, 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study start16 Nov 2006
- Primary completion31 Oct 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Jerome Lejeune
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Jérôme Lejeune
- Responsible party
- Sponsor
- Investigators
- Martine Conte, M.D., Principal investigator, Institut Jerome LejeuneFranck STURTZ, M.D., Study director, Institut Jerome Lejeune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394290
- Sponsor's protocol ID
- IJL-PPC-EP02
- Other IDs
- Morphee
- Acronym
- Morphee
- Status last verified
- Oct 2012
- First submitted
- 31 Oct 2006
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Resta O, Barbaro MP, Giliberti T, Caratozzolo G, Cagnazzo MG, Scarpelli F, Nocerino MC. Sleep related breathing disorders in adults with Down syndrome. Downs Syndr Res Pract. 2003 Aug;8(3):115-9. doi: 10.3104/reports.138.
PubMed 14502839
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients
- ClinicalTrials.gov ID
- NCT00394290
- Acronym / sponsor ID
- Morphee / IJL-PPC-EP02
- Conditions
- Down Syndrome, Obstructive Sleep Apnea Syndrome
- Keywords
- Down Syndrome, Obstructive Sleep Apnea Syndrome, Continuous Positive Pressure, Hypersomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Institut Jerome LejeuneUniversity, hospital or other
- Collaborators
- Fondation Jérôme Lejeune
- Study start
- 16 Nov 2006 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 1 Nov 2006 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPC | Experimental | Device: Continuous Positive PressureNight time device for positive pulmonary pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Down Syndrome patients with an Obstructive Sleep Apnea Syndrome
- more than 18 years old
Key exclusion criteria (4 listed)
- predictable non-compliance of device
- non-compensated cardiopathy
- non-stable thyroxin treatment
- non-stable diabetes
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 |
|---|---|---|
| Continuous Positive PressureNighttime continuous positive pressure device, to be used every day | Device | PPC |
Primary outcome
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)
Time frame: 0 and 3 months
1 secondary outcome
Tolerability
Time frame: 0, 3 and 12 months
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 26 Mar 2019.
- Background: PubMed 14502839Resta O, Barbaro MP, Giliberti T, Caratozzolo G, Cagnazzo MG, Scarpelli F, Nocerino MC. Sleep related breathing disorders in adults with Down syndrome. Downs Syndr Res Pract. 2003 Aug;8(3):115-9. doi: 10.3104/reports.138.
Related trials for Down Syndrome
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
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.
Martine Conte, M.D. principal investigator
Institut Jerome Lejeune
Franck STURTZ, M.D. study director
Institut Jerome Lejeune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Pressure in people with Down Syndrome and Obstructive Sleep Apnea Syndrome, run by Institut Jerome Lejeune at 1 site in France.
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 4 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 26 Mar 2019. 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 France. 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?
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months) (time frame: 0 and 3 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 NCT00394290, which also lists 1 linked publication.
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 26 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.