Sleep in Patients With Cystic Fibrosis | NCT00804661

Studies
Sleep in Patients With Cystic Fibrosis

NCT00804661

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jun 3, 2010Estimated

Enrollment

76Actual

Phase

Not provided

Conditions

Cystic Fibrosis

Interventions

SENTEC device

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Dec 8, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2010

Last Update Posted Date

Jun 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Children and adults with cystic fibrosis	Device: SENTEC device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SENTEC device	Device	Nocturnal recording SAO2 and PtcCO2 and wrist movements by means of actigraphy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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%		At the inclusion visit

Secondary Outcomes

Measure	Description	Time Frame
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)		At the inclusion visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients from the pneumology centers participating to the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brigitte Fauroux, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AP-HP, Armand Trousseau hospital		Paris		75012	France

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

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