Comparison of CPAP Modalities for OSA Treatment

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP Fixed Pressure

• Registration Number: NCT03212209
• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa

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.

Detailed Description

Obstructive sleep apnea (OSA) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. Despite being the most effective treatment for OSA, 46 to 83% of patients do not adhere to CPAP. New technologies for CPAP treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. As an example, the FLEX- PLUS technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. Sensawake is another technology which evaluates breathing pattern changes during CPAP therapy. When the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. However, it is not clear whether CPAP FLEX- PLUS or Sensawake are superior compared with fixed pressure CPAP, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. Objective: To compare the effect of fixed pressure CPAP, CPAP FLEX- PLUS and Sensawake on sleep and compliance parameters in patients with moderate to severe OSA. Methods: Fifty male patients with moderate to severe OSA will be included in a crossover design study. All patients will use each CPAP modality for 30 days in a randomized order, namely CPAP with Fixed Pressure, Flex- PLUS and Sensawake. A week of washout period will be applied between treatments. All patients will wear the same nasal mask brand. At the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out Epworth, FOSQ, Pittsburgh questionnaires and a visual analogue scale assessing CPAP side effects and patient´s comfort. Finally, adherence to CPAP modalities will be systematically checked.

Study Timeline

• Study Start: 2017-04-28
• Study First Submitted: 2017-05-05
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Last Update Submitted: 2017-12-16
• Last Update Posted: 2017-12-19
• Primary Completion: 2018-02-14
• Study Completion: 2018-07-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• male gender
• apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep
• 30-65 years-old
• body mass index (BMI) ≤40 Kg/m²

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP C- Flex-Plus by Philips Respironics	CPAP Fixed Pressure	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.
CPAP with Sensawake by Fisher and Paykel	CPAP Fixed Pressure	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.
CPAP fixed pressure	CPAP Fixed Pressure	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.

Primary Outcome Measures

Name	Time	Method
Flow limitation	4 weeks after each CPAP modality completion	Flow limitation in percentage of total sleep time. The flow limitation will be assessed by the flow curve obtained in the polysomnographic recording.

Secondary Outcome Measures

Name	Time	Method
Adherence to CPAP treatment	4 weeks after each CPAP modality completion	Adherence to CPAP treatment will be evaluated by CPAP SD card download data
Wake time after sleep onset	4 weeks after each CPAP modality completion	Wake time after sleep onset assessed by polysomnographic recording
Arousal index	4 weeks after each CPAP modality completion	Number of arousals per hour of sleep assessed by polysomnographic recording

Trial Locations

Locations (1)

Evelyn Brasil; 🇧🇷 São Paulo, Brazil