Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104880
Recruitment Status : Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
University Hospital Virgen de las Nieves
Information provided by (Responsible Party):
Almudena Carneiro Barrera, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Continuous positive airway pressure (CPAP) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Uncontrolled before‐and‐after study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure: the ADIPOSA Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 14, 2019
Estimated Study Completion Date : October 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Sleep Apnea

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Change in body mass index (BMI) [ Time Frame: Three months ]
    Change in body mass index from baseline to post-intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104880


Locations
Layout table for location information
Spain
University of Granada
Granada, Spain, 18011
Sponsors and Collaborators
Universidad de Granada
University Hospital Virgen de las Nieves
Investigators
Layout table for investigator information
Study Director: Gualberto Buela-Casal, PhD Universidad de Granada

Publications:
Layout table for additonal information
Responsible Party: Almudena Carneiro Barrera, Teaching and research academic staff, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04104880     History of Changes
Other Study ID Numbers: ADIPOSA-19
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Almudena Carneiro Barrera, Universidad de Granada:
obstructive sleep apnea
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases