The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )

Sponsor

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05894733

Collaborator

(none)

128

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators planned to investigate the effect of close monitoring on compliance and the factors affecting compliance among patients receiving PAP treatment due to OSA.This study was a single-center, prospective, randomized, controlled study approved by the hospital's ethics committee.One hundred twenty-eight patients were randomized as group one or two as group 1 is the study and group 2 is the control group. The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.

The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months. The patients who came to the control were asked if there were any problems with the device and any difficulties in use, and they were again informed about the devices and masks.

Condition or Disease	Intervention/Treatment	Phase
Patient Compliance Sleep Disorder Obstructive Sleep Apnea of Adult	Other: study group Other: control group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Nov 1, 2022

Actual Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 1: The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.	Other: study group Calling with phone frequently(15.th day, 1 month , 3 month, 6 month ) and face to face interwiew on first, 3 th and 6th month
Other: 2 2:The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months	Other: control group first and sixth month face to face interwiew

Arm

Intervention/Treatment

Other: 1

1: The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.

Other: study group

Calling with phone frequently(15.th day, 1 month , 3 month, 6 month ) and face to face interwiew on first, 3 th and 6th month

Other: 2

2:The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months

Other: control group

first and sixth month face to face interwiew

Outcome Measures

Primary Outcome Measures

follow-up [1 year]
Short-term compliance( mean duration time to use CPAP therapy) was measured during the first follow-up, and long-term compliance was measured during the last follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:, .newly diagnosed OSA with PSG , and underwent PAP titration

Exclusion Criteria:

. unfollowed patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Makbule Özlem	Maltepe	İstanbul	Turkey

Sponsors and Collaborators

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

Investigators

Principal Investigator: makbule özlem akbay, md, sureyyapasa chest diseases center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Makbule Özlem Akbay, medical doctor, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05894733

Other Study ID Numbers:

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Sleep Wake Disorders

Study Results

No Results Posted as of Jun 8, 2023