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

Overview

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.

Full Title of Study: “Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure: the ADIPOSA Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 14, 2019

Interventions

  • Device: Continuous positive airway pressure (CPAP)
    • Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention

Arms, Groups and Cohorts

  • Experimental: Continuous Positive Airway Pressure (CPAP) group
    • Three-month CPAP use

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad de Granada
  • Collaborator
    • University Hospital Virgen de las Nieves
  • Provider of Information About this Clinical Study
    • Principal Investigator: Almudena Carneiro Barrera, Teaching and research academic staff – Universidad de Granada
  • Overall Official(s)
    • Gualberto Buela-Casal, PhD, Study Director, Universidad de Granada

References

Carneiro-Barrera A, Díaz-Román A, Guillén-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.

Carneiro-Barrera A, Amaro-Gahete FJ, Díaz-Román A, Guillén-Riquelme A, Jurado-Fasoli L, Sáez-Roca G, Martín-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). pii: E2227. doi: 10.3390/nu11092227.

Sánchez AI, Martínez P, Miró 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. Review.

Jurádo-Gámez 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.

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