Sleep apnea phenotypes among Latin American women
| ISRCTN | ISRCTN11936746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11936746 |
| Secondary identifying numbers | 128269 |
- Submission date
- 01/09/2023
- Registration date
- 01/09/2023
- Last edited
- 01/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Obstructive sleep apnea (OSA) occurs when the muscles that support the soft tissues in the throat, such as the tongue and soft palate, temporarily relax and cut off breathing during sleep. This study aims to understand the clinical phenotypes of the Hispanic/Latino community with OSA. In particular, the researchers are trying to identify what aspects of OSA adversely affect the cardiovascular system. In parallel, they will try to understand why recent studies in sleep apnea failed to show the effectiveness of CPAP, the gold standard treatment for OSA, in reducing the risk of major outcomes.
One reason that the impact of OSA on health outcomes remains disputed is that the golden standard metric, such as apnea-hypopnea index (AHI), used to quantify OSA severity, fails to capture the key aspects of OSA (frequent decreases of oxygen in the blood and arousals from sleep) that have negative effects on the cardiovascular system.
The aims of this study are to: 1) provide clinically and physiologically informed metrics to capture the OSA burden among Latin American women, 2) establish their generalizability in this minority group, and 3) supply clinicians with validated predictive models to assess OSA risk in Latin American women. This will enhance patient selection, involve this underrepresented group, and improve quality of life and health outcomes.
Who can participate?
Women over the age of 18 years with suspected OSA (snoring symptoms, apneas observed by bed partner or excessive daytime sleepiness or major cardiovascular illnesses)
What does the study involve?
The aim is to define potential subtypes of patients using symptoms-based, oximetric-based, and clinical-based approaches.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. Participants will receive the usual care.
Where is the study run from?
Brigham and Women's Hospital (USA)
When is the study starting, and how long is it expected to run for?
September 2022 to October 2024
Who is funding the study?
1. The Chest Foundation (USA)
2. Universidad de Concepcion (Chile)
Who is the main contact?
Dr Gonzalo Labarca, glabarcat@gmail.com
Contact information
Principal Investigator
330 Brookline Ave, KS034
Boston
02115
United States of America
 ORCID ID |
0000-0002-0069-3420 |
|---|---|
| Phone | +1 (0)6179552145 |
| glabarcat@gmail.com |
Principal Investigator
330 Brookline Ave, KS034
Boston
02115
United States of America
| ORCID ID |
0000-0002-0069-3420 |
|---|---|
| Phone | +1 (0)6179552145 |
| glabarca@bwh.harvard.edu |
Study information
| Study design | Multicenter prospective cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Phenotyping Obstructive Sleep Apnea in Latin American women: The Latin American Sleep Network (LATAM Sleep Net) |
| Study acronym | LATAM - OSA in women |
| Study hypothesis | The central hypothesis is that sleep apnea-specific hypoxic burden (SASHB) and delta heart rate (∆HR) can identify an OSA phenotype among Latin American women with an increased risk of CPAP adherence in the short term and different burden of comorbidities. This hypothesis was formulated based on our preliminary solid data, including other communities and most males, in which SASHB was associated with worse health outcomes. In addition, ∆HR predicted increased cardiovascular outcomes and their combination provided more robust findings than the two measures in isolation. This project will examine how SASHB and ∆HR are distributed across women and modify CPAP adherence using prospective data from 16 Latin American sleep clinics. |
| Ethics approval(s) |
Approved 26/09/2022, Mass General Brigham IRB (399 Revolution Drive, Suite 710, Sommerville, 02145, United States of America; +1 (0)857 282 1900; IRB@partners.org), ref: 2022P002262 |
| Condition | Obstructive sleep apnea |
| Intervention | The researchers will determine the following exposures from the raw signal: 1. Sleep Apnea-Specific Hypoxic Burden (SASHB): This metric encapsulates the frequency of upper airway obstructions during sleep (like the AHI) and the duration and depth of respiratory event-related oxygen desaturations. The SASHB is quantified by summing the area under the SpO curve associated with individual apneas and hypopneas. The total sum is then divided by the sleep duration, yielding units of minutes of % desaturation per hour of sleep (%·min/h). 2. OSA-Specific Heart Rate Response (ΔHR): The ΔHR is estimated using pulse signals derived from the photoplethysmography used in the pulse oximetry sensor. Consistent with previous studies, ∆HR is defined as the difference between a maximum heart rate during a subject-specific search window and an event-related minimum heart rate (the minimum heart rate during apneas/hypopneas). Finally, individual-level ∆HR is defined as the mean of all event-specific responses. |
| Intervention type | Not Specified |
| Primary outcome measure | Sleep apnea-specific hypoxic burden (SASHB) and delta heart rate (∆HR) measured using the raw data from the sleep test at baseline |
| Secondary outcome measures | CPAP compliance measured using CPAP device compliance report at 1 month after CPAP treatment |
| Overall study start date | 01/09/2022 |
| Overall study end date | 01/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 15 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target number of participants | 500 |
| Participant inclusion criteria | Women with suspected obstructive sleep apnea |
| Participant exclusion criteria | 1. Other sleep disorders such as periodic limb movement, narcolepsy, and parasomnias 2. Severe pulmonary disease |
| Recruitment start date | 01/09/2023 |
| Recruitment end date | 01/06/2024 |
Locations
Countries of recruitment
- Argentina
- Bolivia
- Chile
- Colombia
- Costa Rica
- Mexico
- Peru
- Uruguay
Study participating centres
Santiago
8320000
Chile
Santiago
8240000
Chile
Concepcion
4070386
Chile
Los Angeles
4451055
Chile
Santiago
8431657
Chile
Santiago
7591047
Chile
13B 161 85
Colombia
Lima
15082
Peru
Parana
E3100
Argentina
Buenos Aires
B1629
Argentina
Merida
97305
Mexico
Montevideo
11600
Uruguay
San Jose
10103
Costa Rica
Bucaramanga
52136
Colombia
Lima
15073
Peru
La Paz
4389464
Bolivia
Buenos Aires
B1872AWK
Argentina
Chubut
u9100auo
Argentina
Sponsor information
Hospital/treatment centre
221 Longwood Ave
Boston
02115
United States of America
| Phone | +1 (0)617 732 5619 |
|---|---|
| kstark3@bwh.harvard.edu | |
| Website | http://www.brighamandwomens.org/ |
"ROR" |
https://ror.org/04b6nzv94 |
Funders
Funder type
University/education
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- CHEST, ACCP CHEST
- Location
- United States of America
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Concepcion, UdeC
- Location
- Chile
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers plan to publish their results after a peer-review process. The results will provide information for future studies that clinicians could use to make patient-centered decisions and that healthcare managers, administrators, and policymakers could use to guide allocation. |
| IPD sharing plan | The datasets generated and analyzed during the current study during this study will be available on request from Dr Gonzalo Labarca (glabarcat@gmail.com). Type of data that will be shared: Raw signal, de-identified baseline information after signing a data user agreement (DUA). Dates of availability: From December 2024 All data was de-identified. |
Editorial Notes
01/09/2023: Study's existence confirmed by the Mass General Brigham IRB.
