Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure (ADIPOSA)

September 14, 2020 updated by: Almudena Carneiro Barrera, Universidad de Granada

Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure: the ADIPOSA Study

Continuous positive airway pressure (CPAP) is the gold-standard treatment for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing in the overall population. CPAP has shown to be effective in reducing apnoea-hypopnoea index (AHI) as well as other OSA polysomnographic outcomes. However, the effectiveness of this device on OSA daily functioning and mood disturbances outcomes still remains unclear. The ADIPOSA study is aimed at determining the effects of three-month CPAP use on anxiety-depression symptoms in patients with OSA. Participants will be adults previously diagnosed with OSA who will be allocated to a CPAP-treatment group. Outcomes will be measured at baseline and intervention end-point (three months) including daytime sleepiness, daily functioning and mood (anxiety and depression symptoms), AHI, other neurophysical and cardiorespiratory polysomnographic outcomes, and body weight. ADIPOSA may serve to establish the effectiveness of CPAP on daytime functioning and mood disturbances commonly found on patients with OSA and, in turn, on other OSA outcomes related to anxiety-depression symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18011
        • University of Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous clinical diagnosis of mild/moderate/severe OSA (AHI > 5) by a healthcare professional
  • Use of CPAP
  • Motivation to participate in the study
  • Willing to provide informed consent

Exclusion Criteria:

  • Presence of any other primary sleep disorder
  • Presence of any mental disorder (including depression, anxiety, and addiction to alcohol or other substances)
  • Presence of any other severe organic disease, except for those comorbid to OSA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Continuous Positive Airway Pressure (CPAP) group
Three-month CPAP use
Device: Continuous positive airway pressure (CPAP)
Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety symptoms measured by State-Trait Anxiety Inventory (STAI)
Time Frame: Three months
Changes in state anxiety and trait anxiety components measured by STAI questionnaire after three-month CPAP usage
Three months
Change in depression symptoms measured by Beck's Depression Inventory-Fast Screen (BDI-FS)
Time Frame: Three months
Changes in depression symptoms measured by BDI-FS questionnaire after three-month CPAP usage
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention
Time Frame: Three months
Change in apnoea (airflow reduction greater than or equal to 90%) and hypopnoea (airflow reduction greater than or equal to 30%) episodes per hour of sleep, from baseline to post-intervention.
Three months
Change in oxygen desaturation index (ODI) from baseline to post-intervention.
Time Frame: Three months
Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.
Three months
Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
Time Frame: Three months
Change in the difficulty in maintaining a desired level of wakefulness, measured by the Epworth sleepiness scale (ESS) from baseline to post-intervention. ESS is a 4-point scale (0 = no chance of dozing, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing) that measures the usual chances of dozing off or falling asleep while engaged in eight different activities. An ESS total score from 0 to 9 is considered to be normal while an ESS total score > 9 indicates high daytime sleepiness.
Three months
Change in body mass index (BMI)
Time Frame: Three months
Change in body mass index from baseline to post-intervention
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Collaborators

University Hospital Virgen de las Nieves

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

October 14, 2019

Study Completion (ACTUAL)

October 14, 2019

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (ACTUAL)

September 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADIPOSA-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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