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

NCT04104880 | Completed DMC

• 1 other identifier: ADIPOSA-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea

Outcome Measures

Primary Outcomes (2)

• 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

  Three months

• 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

  Three months

Secondary Outcomes (4)

• Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention

  Three months

• Change in oxygen desaturation index (ODI) from baseline to post-intervention.

  Three months

• Change in excessive daytime sleepiness (EDS) from baseline to post-intervention

  Three months

• Change in body mass index (BMI)

  Three months

Study Arms (1)

Continuous Positive Airway Pressure (CPAP) group

EXPERIMENTAL

Three-month CPAP use

Device: Continuous positive airway pressure (CPAP)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention

Continuous Positive Airway Pressure (CPAP) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead
• University Hospital Virgen de las Nieves: collaborator

Study Sites (1)

University of Granada

Granada, 18011, Spain

Location

Related Publications (4)

• 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.

  PMID: 30609450 BACKGROUND

• 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.

  PMID: 31540168 BACKGROUND

• 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.

  PMID: 19201228 BACKGROUND

• 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.

  PMID: 25976943 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Gualberto Buela-Casal, PhD

  Universidad de Granada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching and research academic staff

Model Details: Uncontrolled before-and-after study

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: April 1, 2019
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)