NCT02289625

Brief Summary

Abstract Obstructive sleep apnea syndrome (OSA) is characterized by complete or partial collapse of a narrowed pharynx and it's associated with reduction in cerebral blood flow, cardiovascular disease, and neuropsychological deficits and reduces survival. In patients with AOS structural, metabolic and hypoperfusion cerebral were associated not only with physiological functions but also with attention and executive function. There is a higher association between apnea hypopnea index and Mini-Mental State Examination in individuals with the exon 4 of APO E gene, indicating that exon 4 of APO E gene confers an increased risk for cognitive decline in individuals with sleep apnea. The analysis of presence and consequences of OSA in cerebral structure, inflammation and neurovascular control can permit a better investigation of abnormalities in these individuals and implement interventions to reduce the risk of development of cognitive and cardiovascular impairment. The non-pharmacological intervention through exercise training can represent an important strategy for improvement in cerebral alterations, cognition and reduction in sleep apnea index. The purpose of present study is investigate the volume and metabolism cerebral, neurovascular control, cognition and exon 4 of APO E gene and their

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

9 years

First QC Date

October 14, 2014

Last Update Submit

March 25, 2020

Conditions

Keywords

Obstructive Sleep Apneacognitionneurovascular functionbrain metabolismexercise training

Outcome Measures

Primary Outcomes (1)

  • effects of exercise training in patients with sleep apnea

    structure and cerebral metabolism will be measure with Magnetic Resonance and regional blood flow. Cognition will be evaluate by neurocognitive tests. All measures will be applied before and after exercise training intervention.

    6 month of exercise training intervention.

Study Arms (2)

Attentional performance in OSA

ACTIVE COMPARATOR

To investigate the attentional performance and muscle sympathetic nerve activity (MSNA) response during Color Word Stroop Test (CWST) in patients with obstructive sleep apnea (OSA) before and after intervention with exercise training.Individuals with no other comorbidities (age=52±1 years, body mass index=29±0.4) were divided in control (n=15) and untreated OSA (n=20) defined by polysomnography.

Other: Exercise Training

metaboreflex in OSA

ACTIVE COMPARATOR

To investigate the metaboreflex control of MSNA before and after intervention with exercise training in patients with obstructive sleep apnea. Methods: Thirty-five patients underwent conventional polysomnography. The MSNA was assessed by microneurography technique. Beat to beat blood pressure was measured during 4 minutes at rest, 3 minutes of isometric exercise at 30% maximal voluntary contraction, followed by 2 minutes of occlusion of the circulation in previously exercised muscle. The metaboreflex sensitivity was calculated during the first and second minutes of circulatory occlusion when metaboreceptors are evaluated independently of central command and muscle mechanoreceptors.

Other: Exercise Training

Interventions

six month of Exercise training will be conducted in individuals with moderate to severe sleep apnea. The training include aerobic exercise, resistance exercise, flexibility.

Attentional performance in OSAmetaboreflex in OSA

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • apparently healthy individual
  • realize all tests
  • participate in exercise training if selected by training group

You may not qualify if:

  • Body mass index \> 35 kg/m2
  • cardiopulmonary disease
  • chronic renal disease
  • diabetes mellitus
  • atrial fibrillation, pacemaker
  • hypertension or renal failure
  • echocardiographic evidence of impaired left ventricular function (ejection fraction \>45%)
  • history of psychiatric disorders
  • dementia or other neurodegenerative disorders
  • a history of smoking or alcohol abuse (2 or more drinks per day)
  • any sleep apnea treatment, story of circadian desynchrony (e.g. shift workers), incomplete 2 years of formal education, resting BP lower than 140/90 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linda Massako Ueno

São Paulo, 01313020, Brazil

Location

Related Publications (4)

  • Ueno-Pardi LM, Souza-Duran FL, Matheus L, Rodrigues AG, Barbosa ERF, Cunha PJ, Carneiro CG, Costa NA, Ono CR, Buchpiguel CA, Negrao CE, Lorenzi-Filho G, Busatto-Filho G. Effects of exercise training on brain metabolism and cognitive functioning in sleep apnea. Sci Rep. 2022 Jun 8;12(1):9453. doi: 10.1038/s41598-022-13115-2.

  • Goya TT, Ferreira-Silva R, Gara EM, Guerra RS, Barbosa ERF, Toschi-Dias E, Cunha PJ, Negrao CE, Lorenzi-Filho G, Ueno-Pardi LM. Exercise training reduces sympathetic nerve activity and improves executive performance in individuals with obstructive sleep apnea. Clinics (Sao Paulo). 2021 Sep 3;76:e2786. doi: 10.6061/clinics/2021/e2786. eCollection 2021.

  • Ueno-Pardi LM, Guerra RS, Goya TT, Silva RF, Gara EM, Lima MF, Nobre TS, Alves MJNN, Trombetta IC, Lorenzi-Filho G. Muscle Metaboreflex Control of Sympathetic Activity in Obstructive Sleep Apnea. Med Sci Sports Exerc. 2017 Jul;49(7):1424-1431. doi: 10.1249/MSS.0000000000001242.

  • Goya TT, Silva RF, Guerra RS, Lima MF, Barbosa ER, Cunha PJ, Lobo DM, Buchpiguel CA, Busatto-Filho G, Negrao CE, Lorenzi-Filho G, Ueno-Pardi LM. Increased Muscle Sympathetic Nerve Activity and Impaired Executive Performance Capacity in Obstructive Sleep Apnea. Sleep. 2016 Jan 1;39(1):25-33. doi: 10.5665/sleep.5310.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Linda M Ueno, Phd

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Linda Massako Ueno

Study Record Dates

First Submitted

October 14, 2014

First Posted

November 13, 2014

Study Start

October 1, 2010

Primary Completion

October 1, 2019

Study Completion

December 31, 2022

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations