NCT05894733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

May 26, 2023

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

OTHER

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

2

OTHER

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

Interventions

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

1

first and sixth month face to face interwiew

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • unfollowed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makbule Özlem

Maltepe, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient ComplianceSleep Wake Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • makbule özlem akbay, md

    sureyyapasa chest diseases center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 8, 2023

Study Start

July 1, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations