NCT02517346

Brief Summary

The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 15, 2016

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

July 30, 2015

Last Update Submit

April 14, 2016

Conditions

Sleep Apnea Syndrome

Keywords

CPAP complianceTelemonitoringStandard managementCost effectiveness

Outcome Measures

Primary Outcomes (1)

  • CPAP adherence at 3 months

    Number of hours of use per day of CPAP according to the internal clock of the CPAP device

    3 months

Secondary Outcomes (15)

  • Patients' satisfaction at 3 months

    3 months

  • Cost effectiveness at 3 months

    3 months

  • Change from baseline in quality of life at 3 months

    3 months

  • Fast detection of the non-adherent patient with telemonitoring

    3 months

  • Change in blood pressure at 3 months

    3 months

  • +10 more secondary outcomes

Study Arms (2)

Standard follow up-Sleep Unit

ACTIVE COMPARATOR

Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit

Other: Standard follow-up

Telemonitoring

EXPERIMENTAL

Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system

Other: Telemonitoring

Interventions

Standard follow-upOTHER

Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Standard follow up-Sleep Unit
TelemonitoringOTHER

Follow up by telemonitoring system during 3 months

Telemonitoring

Eligibility Criteria

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

You may qualify if:

  • Men and Women over 18 years old
  • Diagnosed as OSA and requiring CPAP treatment
  • Written informed consent form signed.

You may not qualify if:

  • Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders)
  • Severe heart failure
  • Severe chronic pathology associated
  • Psychiatric disorder
  • Periodic leg movements
  • Pregnancy
  • Other dyssomnias or parasomnias
  • Patients already treated with CPAP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Arnau de Vilanova-Santa María

Lleida, Lleida, 25198, Spain

Location

Related Publications (1)

  • Turino C, de Batlle J, Woehrle H, Mayoral A, Castro-Grattoni AL, Gomez S, Dalmases M, Sanchez-de-la-Torre M, Barbe F. Management of continuous positive airway pressure treatment compliance using telemonitoring in obstructive sleep apnoea. Eur Respir J. 2017 Feb 8;49(2):1601128. doi: 10.1183/13993003.01128-2016. Print 2017 Feb.

    PMID: 28179438DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ferran Barbe, MD

    Hospital Arnau de Vilanova. IRB Lleida. CIBERes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 7, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

April 15, 2016

Record last verified: 2015-08

Locations

ES(1)