Comorbid Insomnia and Sleep Apnea

• Conditions: Obstructive Sleep Apnea; Insomnia

• Registration Number: NCT04274400
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

Insomnia and OSA coexist in clinical populations, but the prevalence of comorbid insomnia among OSA patients in the community and risk factors remain poorly known. Little is known about the impact of sleep apnea and insomnia on the quality of life and quality of sleep compared to the presence of one of the sleep disorders alone. Our hypothesis is that the co-existence of OSA and insomnia is high in our community. We also hypothesized that the co-existence of OSA and insomnia promotes greater impairment of quality of life and quality of sleep when compared to the presence of OSA or insomnia alone.

Patients referred to polysomnography will be submitted to 6 questionnaires to assess daytime sleepiness (EPWORTH), insomnia severity index (ISI), anxiety and depression assessment (Beck's anxiety and depression inventory), quality of life assessment(WHOQOL- BREF) and sleep quality assessment (Pittsburgh questionnaire) and they will also be submitted to a polysomnography type III.

It will be calculated the frequency of insomnia, OSA and the comorbidity between insomnia and OSA in the sample. It will be analysed correlations between the insomnia severity index, apnea and hypopnea index, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck's anxiety and depression inventory) and Pittsburgh sleep quality scale. Insomnia severity index scores, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck anxiety and depression inventory) and Pittsburgh sleep quality scale will be compared according to the presence and absence of OSA and the presence and absence of insomnia and the presence of the comorbidity insomnia and OSA.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-13
• Last Update Submitted: 2020-02-13
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18
• Study Start: 2020-03-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

-Individuals who will participate in the task force for the diagnosis of sleep apnea promoted by the State Department of Health in an agreement signed with the Heart Institute

Exclusion Criteria

• individuals under 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia	6 months	Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia

Secondary Outcome Measures

Name	Time	Method
Correlations between scales: EPWORTH, ISI, Beck's anxiety and depression inventory, WHOQOL-BREF and Pittsburgh questionnaire	6 months	Correlations between scales: EPWORTH, ISI, Beck's anxiety and depression inventory, WHOQOL-BREF and Pittsburgh questionnaire

Trial Locations

Locations (1)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil