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Lifestyle Intervention for OSA in Adults

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, weight loss, lifestyle intervention, continuous positive airway pressure, OSA, CPAP

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Previous clinical diagnosis of moderate/severe OSA (AHI > 15) by a healthcare professional.
  • Male patients aged between 18-65 years.
  • Body mass index > 25 kg/m2.
  • Use of CPAP
  • Motivation to participate in the study.
  • Signed informed consent form.

Exclusion Criteria:

  • Sleep disorder other than OSA
  • Clinically significant psychiatric, neurological, or medical disorders other than OSA
  • Use of prescription drugs or clinically significant drugs affecting sleep

Sites / Locations

  • University of Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle Intervention Group (LIG)

Control group

Arm Description

Participants from this group will receive a cognitive-behavioral intervention addressing weight loss and lifestyle habits such as hypocaloric diet, moderate exercise, smoking and alcohol avoidance, and sleep hygiene. This behavioral intervention will be combined with the usual treatment for OSA, i.e. CPAP.

Participants from the control group will not receive any type of intervention apart from the usual care (CPAP).

Outcomes

Primary Outcome Measures

Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention.
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.

Secondary Outcome Measures

Change in oxygen desaturation index (ODI) from baseline to post-intervention.
Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.
Change in oxygen saturation (SaO2) mean from baseline to post-intervention
Change in the average of oxygen saturation from baseline to post-intervention
Change in oxygen saturation (SaO2) nadir from baseline to post-intervention
Minimum oxygen saturation from baseline to post-intervention
Change in sleep efficiency from baseline to post-intervention
Change in the total sleep time/total time in bed from baseline to post-intervention
Change in light sleep (N1 and N2 stages) from baseline to post-intervention
Change in the percentage of light sleep (N1 and N2 stages) from baseline to post-intervention
Change in deep sleep (N3 stage) from baseline to post-intervention
Change in the percentage of deep sleep (N3 stage) from baseline to post-intervention
Change in rapid eye movement (REM) sleep from baseline to post-intervention
Change in the percentage of REM sleep from baseline to post-intervention
Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
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 Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention.
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. This scale includes a total of 19 self-rated items combined to form seven component scores i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction), each of which has a range of 0-3 points. The sum of these seven PSQI component scores is considered to obtain a global PSQI score (ranging from 0-21), with higher scores indicating poorer sleep quality.
Change in Wake After Sleep Onset (WASO) from baseline to post-intervention
Change in Wake After Sleep Onset (WASO; minutes) from baseline to post-intervention
Change in body weight (kg) from baseline to post-intervention
Change in body weight (kg) from baseline to post-intervention
Change in fat mass (kg) from baseline to post-intervention
Change in fat mass (kg) from baseline to post-intervention
Change in mean blood pressure (mm HG) from baseline to post-intervention
Change in mean blood pressure (mm HG) from baseline to post-intervention
Change in plasma glucose (mg/dL) from baseline to post-intervention
Change in plasma glucose (mg/dL) from baseline to post-intervention
Change in total cholesterol (mg/dL) from baseline to post-intervention
Change in total cholesterol (mg/dL) from baseline to post-intervention
Change in total triglycerides (mg/dL) from baseline to post-intervention
Change in total triglycerides (mg/dL) from baseline to post-intervention

Full Information

First Posted
February 20, 2019
Last Updated
January 9, 2021
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03851653
Brief Title
Lifestyle Intervention for OSA in Adults
Official Title
Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 13, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI > 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, weight loss, lifestyle intervention, continuous positive airway pressure, OSA, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention Group (LIG)
Arm Type
Experimental
Arm Description
Participants from this group will receive a cognitive-behavioral intervention addressing weight loss and lifestyle habits such as hypocaloric diet, moderate exercise, smoking and alcohol avoidance, and sleep hygiene. This behavioral intervention will be combined with the usual treatment for OSA, i.e. CPAP.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants from the control group will not receive any type of intervention apart from the usual care (CPAP).
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
Cognitive-behavioural intervention for weight loss and lifestyle change
Primary Outcome Measure Information:
Title
Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention.
Description
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.
Time Frame
Post-intervention (2 months)
Secondary Outcome Measure Information:
Title
Change in oxygen desaturation index (ODI) from baseline to post-intervention.
Description
Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.
Time Frame
Post-intervention (2 months)
Title
Change in oxygen saturation (SaO2) mean from baseline to post-intervention
Description
Change in the average of oxygen saturation from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in oxygen saturation (SaO2) nadir from baseline to post-intervention
Description
Minimum oxygen saturation from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in sleep efficiency from baseline to post-intervention
Description
Change in the total sleep time/total time in bed from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in light sleep (N1 and N2 stages) from baseline to post-intervention
Description
Change in the percentage of light sleep (N1 and N2 stages) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in deep sleep (N3 stage) from baseline to post-intervention
Description
Change in the percentage of deep sleep (N3 stage) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in rapid eye movement (REM) sleep from baseline to post-intervention
Description
Change in the percentage of REM sleep from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
Description
Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
Time Frame
Post-intervention (2 months)
Title
Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
Description
Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
Time Frame
Post-intervention (2 months)
Title
Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
Description
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.
Time Frame
Post-intervention (2 months)
Title
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention.
Description
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. This scale includes a total of 19 self-rated items combined to form seven component scores i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction), each of which has a range of 0-3 points. The sum of these seven PSQI component scores is considered to obtain a global PSQI score (ranging from 0-21), with higher scores indicating poorer sleep quality.
Time Frame
Post-intervention (2 months)
Title
Change in Wake After Sleep Onset (WASO) from baseline to post-intervention
Description
Change in Wake After Sleep Onset (WASO; minutes) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in body weight (kg) from baseline to post-intervention
Description
Change in body weight (kg) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in fat mass (kg) from baseline to post-intervention
Description
Change in fat mass (kg) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in mean blood pressure (mm HG) from baseline to post-intervention
Description
Change in mean blood pressure (mm HG) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in plasma glucose (mg/dL) from baseline to post-intervention
Description
Change in plasma glucose (mg/dL) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in total cholesterol (mg/dL) from baseline to post-intervention
Description
Change in total cholesterol (mg/dL) from baseline to post-intervention
Time Frame
Post-intervention (2 months)
Title
Change in total triglycerides (mg/dL) from baseline to post-intervention
Description
Change in total triglycerides (mg/dL) from baseline to post-intervention
Time Frame
Post-intervention (2 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous clinical diagnosis of moderate/severe OSA (AHI > 15) by a healthcare professional. Male patients aged between 18-65 years. Body mass index > 25 kg/m2. Use of CPAP Motivation to participate in the study. Signed informed consent form. Exclusion Criteria: Sleep disorder other than OSA Clinically significant psychiatric, neurological, or medical disorders other than OSA Use of prescription drugs or clinically significant drugs affecting sleep
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gualberto Buela-Casal, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jonatan R. Ruiz, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Almudena Carneiro-Barrera, MD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data (IPD) that underlie results in a publication
IPD Sharing Time Frame
After publication
Citations:
PubMed Identifier
30609450
Citation
Carneiro-Barrera A, Diaz-Roman A, Guillen-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.
Results Reference
background
PubMed Identifier
19201228
Citation
Sanchez AI, Martinez P, Miro 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.
Results Reference
background
PubMed Identifier
27296826
Citation
Aiello KD, Caughey WG, Nelluri B, Sharma A, Mookadam F, Mookadam M. Effect of exercise training on sleep apnea: A systematic review and meta-analysis. Respir Med. 2016 Jul;116:85-92. doi: 10.1016/j.rmed.2016.05.015. Epub 2016 May 21.
Results Reference
background
PubMed Identifier
28215266
Citation
Iftikhar IH, Bittencourt L, Youngstedt SD, Ayas N, Cistulli P, Schwab R, Durkin MW, Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary weight loss for sleep apnea: a network meta-analysis. Sleep Med. 2017 Feb;30:7-14. doi: 10.1016/j.sleep.2016.06.001. Epub 2016 Jun 28.
Results Reference
background
PubMed Identifier
25976943
Citation
Jurado-Gamez 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.
Results Reference
background
PubMed Identifier
31540168
Citation
Carneiro-Barrera A, Amaro-Gahete FJ, Diaz-Roman A, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-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):2227. doi: 10.3390/nu11092227.
Results Reference
background
PubMed Identifier
35807913
Citation
Carneiro-Barrera A, Amaro-Gahete FJ, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Tinahones FJ, Ruiz JR. Effect of a Weight Loss and Lifestyle Intervention on Dietary Behavior in Men with Obstructive Sleep Apnea: The INTERAPNEA Trial. Nutrients. 2022 Jun 30;14(13):2731. doi: 10.3390/nu14132731.
Results Reference
derived
PubMed Identifier
35452108
Citation
Carneiro-Barrera A, Amaro-Gahete FJ, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Buela-Casal G, Ruiz JR. Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e228212. doi: 10.1001/jamanetworkopen.2022.8212.
Results Reference
derived

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Lifestyle Intervention for OSA in Adults

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