Effect of Continuous Positive Airway Pressure on Chronotype, Dietary Intake, and Cardiovascular Risk Markers

NCT04262960 | Unknown

• 1 other identifier: 07034918000005327
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will evaluate chronotype, food intake pattern, and cardiovascular risk markers of elder individuals with OSA, in use of CPAP, when submitted to two weeks of CPAP withdrawal.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Obstructive sleep apnea; Continuous positive airway pressure; Elders; Chronotype; Cardiovascular risk; Food intake

Outcome Measures

Primary Outcomes (1)

• The association between withdrawal CPAP with chronotype, food intake pattern and cardiovascular risk markers.

  Chronotype as defined by the MEQ chronotype categories; food intake pattern dietary assessed by a 3 day food intake diary, and Plasminogen activator inhibitor type 1 (pg/mL) and plasminogen (ng/mL) measured from blood samples by ELISA.

  4 weeks

Secondary Outcomes (7)

• Plasminogen activator inhibitor type 1

  1 week before and two weeks after randomization

• Plasminogen

  1 week before and two weeks after randomization

• Blood pressure

  1 week before and two weeks after randomization

• Chronotype

  1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization

• Sleep habits

  1 week before and 1 week after randomization - MEQ 1 week before and 2 weeks after randomization

Study Arms (2)

active CPAP

ACTIVE COMPARATOR

auto-PAP with therapeutic pressure

Device: Device: active CPAP

sham-CPAP

SHAM COMPARATOR

auto-PAP with pressure less than 1cm H2O

Device: Device: sham-CPAP

Interventions

Device: active CPAP DEVICE

auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients

active CPAP

Device: sham-CPAP DEVICE

The sham-CPAP will be fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al, with pressure that no greater than 1cm H2O.

sham-CPAP

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 to 75 years
• Previous diagnosis of OSA with AHI\> 30 events / hour
• Body mass index below 34,9 kg/m2
• Use of CPAP for more than one year, with an average duration of at least 6 hours per night, confirmed by the device's memory
• Evidence in the device that you have stopped using it previously, for at least two weeks, with no relevant symptoms
• Use of automatic CPAP device with full memory for at least one year, preferably using device model with internet data access
• Subjects physically active and willing to provide informed consent
• Subjects willing to attend visits and blood collections in series

You may not qualify if:

• History of myocardial infarction, stroke or transient ischemic attack (TIA) or peripheral vascular disease.
• History of chronic diseases such as diabetes mellitus ( A fasting plasma glucose (FPG) level of 152 mg/dL or A1C \> 7,5 % ), uncontrolled severe hypertension (SBP \>180 DBP \> 110), renal failure on dialysis, cancer, autoimmune or liver disease
• A significant history of medical or psychiatric disease that may decompensate with altered sleep patterns or impair participation in the trial
• Severe or unstable clinical conditions that may be exacerbated by discontinuation of CPAP (cardiac, pulmonary, renal or other organ disorders not yet treated or worsening of symptoms in the last two months, eg cardiac arrhythmias, congestive heart failure and oxygen-dependent lung disease)
• Another primary sleep disorder that requires intervention with medications.
• Patients with unusual sleep or wake habits, including shift work.
• Professional driver or who crosses paths of more than one hour driving, in which the s sleepiness can be risk of accident.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ruy Silveira Morais Filho, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruy Silveira Morais Filho, PhD

CONTACT

+55 5133598289; rfilho@hcpa.edu.br

Lisette Redondo cotes

CONTACT

55 5133598289; lisetteredondo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 10, 2020
• Study Start: August 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)