Comparison of CPAP Modalities for OSA Treatment

NCT03212209 | Unknown DMC FDA Device

• 1 other identifier: AssociacaoFIP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea; CPAP

Outcome Measures

Primary Outcomes (1)

• Flow limitation

  Flow limitation in percentage of total sleep time. The flow limitation will be assessed by the flow curve obtained in the polysomnographic recording.

  4 weeks after each CPAP modality completion

Secondary Outcomes (3)

• Adherence to CPAP treatment

  4 weeks after each CPAP modality completion

• Arousal index

  4 weeks after each CPAP modality completion

• Wake time after sleep onset

  4 weeks after each CPAP modality completion

Study Arms (3)

CPAP C- Flex-Plus by Philips Respironics

EXPERIMENTAL

Four consecutive weeks with CPAP C- FLEX PLUS treatment. After these 4 weeks, patients will undergo full PSG with CPAP FLEX- PLUS. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period.

Device: CPAP Fixed Pressure

CPAP with Sensawake by Fisher and Paykel

EXPERIMENTAL

Four consecutive weeks with CPAP Sensawake treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period.

Device: CPAP Fixed Pressure

CPAP fixed pressure

ACTIVE COMPARATOR

Four consecutive weeks with CPAP fixed pressure treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period.

Device: CPAP Fixed Pressure

Interventions

CPAP Fixed Pressure DEVICE

Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.

Also known as: CPAP C- Flex Plus by Philips Respironics, CPAP with SensAwake by Fisher and Paykel

CPAP C- Flex-Plus by Philips Respironics; CPAP fixed pressure; CPAP with Sensawake by Fisher and Paykel

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male gender
• apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep
• years-old
• body mass index (BMI) ≤40 Kg/m²

You may not qualify if:

• major neurological, psychiatric, cardiac or respiratory disease
• use of psychoactive medication
• other sleep disorders
• patients referred to PSG for Bilevel, considered the need for PAP ≥ 18 cm H2O
• Previous contact with any OSA treatment.

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead
• Fisher and Paykel Healthcare: collaborator
• Philips Respironics: collaborator

Study Sites (1)

Evelyn Brasil

São Paulo, 04024-002, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Dalva Poyares, MD, PhD

  AFIP - Associação de fundo e incentivo a pesquisa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants have never had contact with CPAP, therefore were not aware of PAP modality prescribed. Investigator were also naive, as well as sleep specialist responsible for Polysomnography reports. Only respiratory therapist who was assigned to CPAP clinic was aware of patient´s treatment condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a crossover study comparing different CPAP modalities in a group of patients with moderate to severe OSA.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: July 11, 2017
• Study Start: April 28, 2017
• Primary Completion: February 14, 2018
• Study Completion: July 16, 2018
• Last Updated: December 19, 2017

Record last verified: 2017-07

Locations

BR (1)