Study of lung function, and sleep, and daytime sleepiness, and the behavior of the autonomic nervous system, and anxiety, depression, and stress in chronic renal failure patients.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7yhr4w
• Date of registration: 15/06/2012
• Primary sponsor: Universidade Nove de Julho - UNINOVE - Brazil
• Public title: Study of lung function, and sleep, and daytime sleepiness, and the behavior of the autonomic nervous system, and anxiety, depression, and stress in chronic renal failure patients.
• Scientific title: Study of lung function, and maximal ventilatory pressures, and sleep, and daytime sleepiness, and nocturnal periodic legs moviments, and autonomic nervous system activity, and ansiety, and depression, and stress vulnerability, in chronic kidney disease patients.
• Date of first enrolment: 02/04/2012
• Target sample size: 57
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7yhr4w/
• Study design: Prospective, consecutive, randomized, controlled, double-blind, single arm clinical study.

Countries of recruitment

Brazil

Contacts

• Name: Luís Oliveira
• Affiliation: Universidade Nove de Julho - UNINOVE

• Name: Luís Vicente Oliveira
• Affiliation: Universidade Nove de Julho - UNINOVE

Key inclusion & exclusion criteria

Inclusion criteria: Patients with chronic renal failure candidates to renal transplant with an indication of hemodialysis, that agree to participate in the study;
Both gender;
Aged between 18 and 70 years;
Cognitive level sufficient for understanding the prodedures and fllowing the instructions.
Exclusion criteria: Abuse of alcohol and or drugs;

Age minimum: 18Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

E00-E90

J00-J99

Renal failure, sleep apnea, psychological stress, anxiety, depression and, quality of life.
CID-10 N17
G47.3
F01.145.126.990
F01.470.132
I01.800

Intervention(s)

Will be invited 57 patients to participate in this study patients with chronic renal failure from a specialized nephrology clinical setting. Patients will be consecutively clinically evaluated during 2012/2013 and submitted a sleep study, and antonomic nervous system activity by heart rate variability, and anxiety, and depression, and quality of life questionnaire. The clinical evaluation, polysomnography studies and heart rate variability analysis will be performed in each patient once before and after hemodialysis session. The questionnaires of quality of life and, anxiety, depression and, stress will be applied once in all patients in the study.

Primary Outcome(s)

Decrease of Apnea/hypopnea index by standard overnight polysomnography.

Increase of expiratory flow as flow drop (V'), expressed as the percentage of expiratory peak flow immediately after negative expiratory pressure application. Timepoint: This will be measured after the clinical and demographic collecting data and after obstruction diagnosis by spirometry is discarded.

Increase of periodic leg movements during sleep by the standart overnight polysomnography.

Presence of anxiety and depression checked by cutoff points greater than or equal to nine by the Hospital Anxiety and Depression scale.

Secondary Outcome(s)

Decrease diurnal excessive assessed sleepiness by the Epworth Sleepiness Scale.

Decrease maximal inspiratory pressure and maximal expiratory pressure evaluated by digital manuvacuometer.

Decrease of risk to obstructive sleep apnea through Berlin Questionnaire.

Decrease the neck circunference in centimeters.

Increase of quality of life assessment through the SF36 quality of life questionnaire.

Increase the sleep physiological variables, total sleep time and, sleep latency and, sleep stages and, behavior disturbes assessed by the standart overnight polysomnograph.

Increased simpathetic and decreased parassimpathetic autonomic nervous activity by heart rate variability analysis.

Increased stress with questionnaire Lipp Stress Symptoms Inventory for Adults.

Secondary ID(s)

368856/2010

*****************

Source(s) of Monetary Support

Universidade Nove de Julho - UNINOVE - Brazil

Secondary Sponsor(s)

Universidade Nove de Julho - UNINOVE - Brazil