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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05894733
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: June 2023
• Source: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Exclusion Criteria:

. unfollowed patients

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Patient Compliance
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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
• control group
first and sixth month face to face interwiew

Locations

Country	Name	City	State
Turkey	Makbule Özlem	Maltepe	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follow-up	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.	1 year