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Completed

NCT Number: NCT04104880

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18011, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • University Hospital Virgen de las Nieves

Registry information

Official study title

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

Acronym: ADIPOSA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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