NCT02509247

Brief Summary

Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

June 10, 2015

Last Update Submit

July 23, 2015

Conditions

Sleep Apnea

Keywords

sleep apneaCPAPtelemonitoringtelecare

Outcome Measures

Primary Outcomes (1)

  • Nursing time

    Nursing time includes patient's visit at nurse office, phone calls, check-ups of telemonitoring data and completing patient records

    3 months

Secondary Outcomes (1)

  • CPAP adherence measured with in-built clock counter

    1 year

Study Arms (2)

Telemonitoring group

EXPERIMENTAL

Patients allocated to the telemonitoring group started with wireless telemonitoring after the titration period, i.e. in the beginning of habituation phase of CPAP treatment.

Device: Telemonitoring

Usual care group

NO INTERVENTION

Patients were followed-up during the habituation phase according to hospital's standard procedure.

Interventions

TelemonitoringDEVICE

Wireless telemonitoring

Also known as: Restraxx System (ResMed, Sydney, Australia)
Telemonitoring group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive adult patients commencing CPAP therapy for OSA

You may not qualify if:

  • Patient not able to co-operate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Tarja Saaresranta, MD, Phd

    Hospital District of Southwest Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

July 27, 2015

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

March 1, 2015

Last Updated

July 27, 2015

Record last verified: 2015-07

Locations

FI(1)