Effect of aggressive fluid control on sleep apnea and cardiovascular outcomes in peritoneal dialysis with moderate to severe OSA

Phase 2

• Conditions: Sleep Apnea in Peritoneal Dialysis; Peritoneal Dialysis; OSA

• Registration Number: TCTR20230601006
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study Completion: 2023-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be eligible for entry into the study, patients must satisfy the following criterias:
-New or incumbent peritoneal dialysis patients, more than 18 to less than 80 years of age.
-Patients have moderate-severe OSA (equivalent to apnea plus hypopneas index [AHI] more than 20 per hour of sleep) confirmed by the central sleep laboratory at King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
-Patients are able and willing to give appropriate informed consent.

Exclusion Criteria

Patients will be excluded from entry if ANY of the criteria listed below are met
1.Morbid Obesity with BMI more than 35.0
2.Recent diagnosis of stroke, cognitive dysfunction or neuromuscular disease with bulbar or respiratory system involvement; recent stroke within 12 weeks (about 3 months);
a.previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral haemorrhage) within 90 days prior to informed consent; or
b.previous transient ischaemic event (TIA) of the brain or retina (symptoms less 24 hours) with
the diagnosis confirmed by a neurologist within 30 days prior to informed consent.
c.significant memory, perceptual, or behavioural disorder
d.neurological deficit (e.g., limb paresis)

3.Severe respiratory disease:
a.Severe COPD (FEV1/FVC less than 70% and FEV1 less than 50% predicted)
b.Pulmonary arterial hypertension
c.Resting, awake SaO2 less than 90%
d.Severe nocturnal desaturation more than 10% overnight recording time with arterial oxygen saturation of less than 80%
e.Cheyne-stokes respiration (CSResp)
4.Prior use of CPAP treatment for OSA
5.Technical problems with peritoneal dialysis: TK malposition, recent PD associated infection within 30 days
6.Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example,
a.residence sufficiently remote from the clinic to preclude follow-up clinic visits.
b.co-morbid disease with severe disability or likelihood of death within the next 2 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AHI 3 months Full night sleep test

Secondary Outcome Measures

Name	Time	Method
All-cause mortality 3 months chart review, interview,All-cause mortality 12 months chart review, interview