search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP)
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Granada

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous Positive Airway Pressure (CPAP) group

Arm Description

Three-month CPAP use

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention
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.
Change in oxygen desaturation index (ODI) from baseline to post-intervention.
Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.
Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
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.
Change in body mass index (BMI)
Change in body mass index from baseline to post-intervention

Full Information

First Posted
September 24, 2019
Last Updated
September 14, 2020
Sponsor
Universidad de Granada
Collaborators
University Hospital Virgen de las Nieves
search

1. Study Identification

Unique Protocol Identification Number
NCT04104880
Brief Title
Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure
Acronym
ADIPOSA
Official Title
Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure: the ADIPOSA Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 14, 2019 (Actual)
Study Completion Date
October 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
University Hospital Virgen de las Nieves

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Uncontrolled before-and-after study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Positive Airway Pressure (CPAP) group
Arm Type
Experimental
Arm Description
Three-month CPAP use
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Description
Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention
Primary Outcome Measure Information:
Title
Change in anxiety symptoms measured by State-Trait Anxiety Inventory (STAI)
Description
Changes in state anxiety and trait anxiety components measured by STAI questionnaire after three-month CPAP usage
Time Frame
Three months
Title
Change in depression symptoms measured by Beck's Depression Inventory-Fast Screen (BDI-FS)
Description
Changes in depression symptoms measured by BDI-FS questionnaire after three-month CPAP usage
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention
Description
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.
Time Frame
Three months
Title
Change in oxygen desaturation index (ODI) from baseline to post-intervention.
Description
Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.
Time Frame
Three months
Title
Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
Description
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.
Time Frame
Three months
Title
Change in body mass index (BMI)
Description
Change in body mass index from baseline to post-intervention
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gualberto Buela-Casal, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Study Director
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30609450
Citation
Carneiro-Barrera A, Diaz-Roman A, Guillen-Riquelme A, Buela-Casal G. Weight loss and lifestyle interventions for obstructive sleep apnoea in adults: Systematic review and meta-analysis. Obes Rev. 2019 May;20(5):750-762. doi: 10.1111/obr.12824. Epub 2019 Jan 4.
Results Reference
background
PubMed Identifier
31540168
Citation
Carneiro-Barrera A, Amaro-Gahete FJ, Diaz-Roman A, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Ruiz JR, Buela-Casal G. Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: Rationale, Design and Methodology of the INTERAPNEA Study. Nutrients. 2019 Sep 15;11(9):2227. doi: 10.3390/nu11092227.
Results Reference
background
PubMed Identifier
19201228
Citation
Sanchez AI, Martinez P, Miro E, Bardwell WA, Buela-Casal G. CPAP and behavioral therapies in patients with obstructive sleep apnea: effects on daytime sleepiness, mood, and cognitive function. Sleep Med Rev. 2009 Jun;13(3):223-33. doi: 10.1016/j.smrv.2008.07.002. Epub 2009 Feb 7.
Results Reference
background
PubMed Identifier
25976943
Citation
Jurado-Gamez B, Guglielmi O, Gude F, Buela-Casal G. Effects of continuous positive airway pressure treatment on cognitive functions in patients with severe obstructive sleep apnoea. Neurologia. 2016 Jun;31(5):311-8. doi: 10.1016/j.nrl.2015.03.002. Epub 2015 May 11. English, Spanish.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs