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Comorbid Insomnia and Sleep Apnea

Comorbid Insomnia and Sleep Apnea in Patients Referred to Polysomnography

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04274400
Enrollment
215
Registered
2020-02-18
Start date
2020-03-01
Completion date
2020-06-01
Last updated
2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Obstructive Sleep Apnea

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.

Interventions

None listed

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia6 monthsFrequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia

Secondary

MeasureTime frameDescription
Correlations between scales: EPWORTH, ISI, Beck's anxiety and depression inventory, WHOQOL-BREF and Pittsburgh questionnaire6 monthsCorrelations between scales: EPWORTH, ISI, Beck's anxiety and depression inventory, WHOQOL-BREF and Pittsburgh questionnaire

Countries

Brazil

Contacts

Primary ContactPedro Genta
prgenta@gmail.com5511 993437027
Backup ContactMarcela Yanagimori
1155 963600111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026