Cystic FibrosisSommeilNCT00804661
Sleep in Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to identify the parameters that are associated with nocturnal hypoventilation in children and adults with cystic fibrosis. Included patients will undergo a nocturnal evaluation of their gas exchange and sleep quality by actigraphy during their annual check up. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- SENTEC device
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Jun 2009
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the pneumology centers participating to the study
Who may be able to join
- children > 8 years and adults with CF
- in a stable state (no acute respiratory exacerbation since one month or patient finishing an antibiotic course)
- able to perform reproducible forced expiratory flows
- having a forced expiratory volume in one second ≤ 60% predicted value
- who accepts to perform a sleep study in the hospital during one night
- written agreement to participate to the study
Who cannot join
- acute respiratory exacerbation in the previous month or patient who has not finished an antibiotic course
- Inability or impossibility to perform reproducible forced expiratory flows (pneumothorax during the previous year and/or without surgery)
- having a forced expiratory volume in one second > 60% predicted value
- refusal or impossibility to perform a sleep study in the hospital during one night
- patients receiving long term oxygen therapy or noninvasive positive pressure ventilation
- no social security
- impossibility of a medical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Nocturnal Hypoventilation in Patients With Cystic Fibrosis
The aim of the study is to identify the parameters that are associated with nocturnal hypoventilation in children and adults with cystic fibrosis. Included patients will undergo a nocturnal evaluation of their gas exchange and sleep quality by actigraphy during their annual check up. The aim is thus to identify which parameters (such as lung function parameters) are associated with nocturnal hypercapnia or hypoxemia and/or poor sleep quality
Read the detailed description
Background In patients with cystic fibrosis (CF), respiratory disease is characterised by a progressive and ineluctable decline in lung function. Sleep-disordered breathing may occur at an early stage of lung disease and may impair quality of life. Oxygen therapy or noninvasive positive pressure ventilation may improve nocturnal hypoxemia and hypercapnia.Risk factors for nocturnal hypercapnia or hypoxemia are not well identified in patients with CF.
Type of study : prospective, transversal, open
Methods :
During the annual check up, a sleep study will be performed with a nocturnal recording of a least 6 hours of pulse oximetry (SaO2) and transcutaneous carbon dioxide (PtcCO2) by the SENTEC device and wrist movements by means of actigraphy. The results of the sleep study will be correlated to·
- clinical scores which evaluate sleep quality (such as the PITTSBURG Sleep Quality Score).·
- respiratory function parameters : lung volumes, forced expiratory of the respiratory muscles: maximal inspiratory and expiratory pressures and the sniff nasal inspiratory pressure.·
- nutritional state with the body mass index z-score·
- the presence of arterial pulmonary hypertension on an echocardiography·
- infectious status (colonisation by Staphylococcus aureus or Pseudomonas aeruginosa) and the CFTR genotype.
Expected results This study should be able to document abnormal nocturnal gas exchange and sleep-disordered breathing in patients with CF in a stable state. The identification of parameters associated with nocturnal hypoventilation and/or poor sleep quality will help to screen those patients who will need a sleep study and treatment such as oxygen therapy or noninvasive positive pressure ventilation.
- Conditions
- Cystic Fibrosis
- Being tested
- SENTEC device
- Keywords
- sleep, nocturnal hypoventilation, sleep quality, lung function
- Medical subject headings
- Cystic Fibrosis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENTEC deviceDevice
Also called Nocturnal SAO2/PtcCO2 and wrist movements
Nocturnal recording SAO2 and PtcCO2 and wrist movements by means of actigraphy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children and adults with cystic fibrosis Receives: Device: SENTEC device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine clinical and functional parameters associated with nocturnal hypoventilation defined by· - A mean transcutaneous carbon dioxide pressure (PtcCO2) ≥ 45 mm Hg· - And/or a maximal PtcCO2 ≥ 55 mm Hg· - And/or a PtcCO2 ≥ 45 mm Hg during ≥ 50%
Measured: At the inclusion visit
Secondary outcomes (1)
To determine clinical and functional parameters associated with- sleep -disordered breathing defined by the presence of arousals on actigraphy (Actiwatch™) in children and adults with CF - nocturnal hypoxemia defined by -- a mean pulse oximetry (SaO2)
Measured: At the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Brigitte Fauroux, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804661
- Sponsor's protocol ID
- P070202
- Acronym
- Sommeil
- Status last verified
- May 2010
- First submitted
- 8 Dec 2008
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Nocturnal Hypoventilation in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00804661
- Acronym / sponsor ID
- Sommeil / P070202
- Conditions
- Cystic Fibrosis
- Keywords
- sleep, nocturnal hypoventilation, sleep quality, lung function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Dec 2008 (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 aim of the study is to identify the parameters that are associated with nocturnal hypoventilation in children and adults with cystic fibrosis. Included patients will undergo a nocturnal evaluation of their gas exchange and sleep quality by actigraphy during their annual check up. The aim is thus to identify which parameters (such as lung function parameters) are associated with nocturnal hypercapnia or hypoxemia and/or poor sleep quality
Detailed description
Background In patients with cystic fibrosis (CF), respiratory disease is characterised by a progressive and ineluctable decline in lung function. Sleep-disordered breathing may occur at an early stage of lung disease and may impair quality of life. Oxygen therapy or noninvasive positive pressure ventilation may improve nocturnal hypoxemia and hypercapnia.Risk factors for nocturnal hypercapnia or hypoxemia are not well identified in patients with CF.
Type of study : prospective, transversal, open
Methods :
During the annual check up, a sleep study will be performed with a nocturnal recording of a least 6 hours of pulse oximetry (SaO2) and transcutaneous carbon dioxide (PtcCO2) by the SENTEC device and wrist movements by means of actigraphy. The results of the sleep study will be correlated to·
- clinical scores which evaluate sleep quality (such as the PITTSBURG Sleep Quality Score).·
- respiratory function parameters : lung volumes, forced expiratory of the respiratory muscles: maximal inspiratory and expiratory pressures and the sniff nasal inspiratory pressure.·
- nutritional state with the body mass index z-score·
- the presence of arterial pulmonary hypertension on an echocardiography·
- infectious status (colonisation by Staphylococcus aureus or Pseudomonas aeruginosa) and the CFTR genotype.
Expected results This study should be able to document abnormal nocturnal gas exchange and sleep-disordered breathing in patients with CF in a stable state. The identification of parameters associated with nocturnal hypoventilation and/or poor sleep quality will help to screen those patients who will need a sleep study and treatment such as oxygen therapy or noninvasive positive pressure ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: SENTEC deviceChildren and adults with cystic fibrosis |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the pneumology centers participating to the study
Key inclusion criteria (6 listed)
- children > 8 years and adults with CF
- in a stable state (no acute respiratory exacerbation since one month or patient finishing an antibiotic course)
- able to perform reproducible forced expiratory flows
- having a forced expiratory volume in one second ≤ 60% predicted value
- who accepts to perform a sleep study in the hospital during one night
Key exclusion criteria (7 listed)
- acute respiratory exacerbation in the previous month or patient who has not finished an antibiotic course
- Inability or impossibility to perform reproducible forced expiratory flows (pneumothorax during the previous year and/or without surgery)
- having a forced expiratory volume in one second > 60% predicted value
- refusal or impossibility to perform a sleep study in the hospital during one night
- patients receiving long term oxygen therapy or noninvasive positive pressure ventilation
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 |
|---|---|---|
| SENTEC deviceAlso: Nocturnal SAO2/PtcCO2 and wrist movementsNocturnal recording SAO2 and PtcCO2 and wrist movements by means of actigraphy | Device | 1 |
Primary outcome
To determine clinical and functional parameters associated with nocturnal hypoventilation defined by· - A mean transcutaneous carbon dioxide pressure (PtcCO2) ≥ 45 mm Hg· - And/or a maximal PtcCO2 ≥ 55 mm Hg· - And/or a PtcCO2 ≥ 45 mm Hg during ≥ 50%
Time frame: At the inclusion visit
1 secondary outcome
To determine clinical and functional parameters associated with- sleep -disordered breathing defined by the presence of arousals on actigraphy (Actiwatch™) in children and adults with CF - nocturnal hypoxemia defined by -- a mean pulse oximetry (SaO2)
Time frame: At the inclusion visit
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 3 Jun 2010.
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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.
Brigitte Fauroux, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 7 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 3 Jun 2010. 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?
To determine clinical and functional parameters associated with nocturnal hypoventilation defined by· - A mean transcutaneous carbon dioxide pressure (PtcCO2) ≥ 45 mm Hg· - And/or a maximal PtcCO2 ≥ 55 mm Hg· - And/or a PtcCO2 ≥ 45 mm Hg during ≥ 50% (time frame: At the inclusion visit). 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 3 Jun 2010.