Back to resultsThe Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )
Primary Purpose
Patient Compliance, Sleep Disorder, Obstructive Sleep Apnea of Adult
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
study group
control group
Sponsored by
About this trial
This is an interventional screening trial for Patient Compliance
Eligibility Criteria
Inclusion Criteria:, .newly diagnosed OSA with PSG , and underwent PAP titration Exclusion Criteria: . unfollowed patients
Sites / Locations
- Makbule Özlem
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
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.
2:The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05894733
First Posted
May 26, 2023
Last Updated
June 7, 2023
Sponsor
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05894733
Brief Title
The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )
Official Title
The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance, Sleep Disorder, Obstructive Sleep Apnea of Adult
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
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.
Arm Title
2
Arm Type
Other
Arm Description
2:The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months
Intervention Type
Other
Intervention Name(s)
study group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
first and sixth month face to face interwiew
Primary Outcome Measure Information:
Title
follow-up
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:, .newly diagnosed OSA with PSG , and underwent PAP titration
Exclusion Criteria:
. unfollowed patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
makbule özlem akbay, md
Organizational Affiliation
sureyyapasa chest diseases center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makbule Özlem
City
Maltepe
State/Province
İstanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )
We'll reach out to this number within 24 hrs