Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

Status Completed

Clinical Trial Summary

In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients.

Clinical Trial Description

In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with CPAP therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Patients often report this fact, but it has not been objectivated.

Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients. Sleep schemes and physical activity will be studied with actigraphy.

Study Design : prospective study. Number of patients supposed to be studied: 190

Methods:

Patients Ø OSA patients assessed by polysomnography, showing apnea-hypopnea index > 20, and Epworth Sleepiness Scale Score(ESS) >10 Ø Indication of CPAP therapy

Initial Evaluation :

- Phase 1

- ESS

- BMI

- Questionnaire : Nottingham health profile

- Comorbidities -medical therapy

- Smoking/alcohol Consumption

- Then, we give an Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days

- Phase 2

- Actigraphy report

- Start of CPAP therapy(pressure adjusted according to autoCPAP device report after minimum one night)

Second Evaluation, after 3 months under CPAP:

- Phase 1

§ ESS

- BMI

- CPAP observance report to calculate mean use/day

- Questionnaire : Nottingham health profile

- Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days

- Phase 2: after 1 week under CPAP and actigraphy

- Actigraphy report

- CPAP observance report

- CPAP Tolerance Questionnaire Ø ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01355419
Study type	Observational
Source	Centre Hospitalier Universitaire Saint Pierre
Contact
Status	Completed
Phase	N/A
Start date	August 2010
Completion date	August 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.