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Tirzepatide versus CPAP and Lifestyle Modification for Obstructive Sleep Apnea in Adults ≥ 65 years with Overweight or Obesity – Randomized Trial

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial examines the condition Obstructive sleep apnea in older adults who are overweight or have obesity. The condition causes repeated pauses in breathing during sleep, leading to poor sleep quality and health problems. The study compares three approaches as possible first‑line treatment: a weekly injection of tirzepatide, the use of a Continuous Positive Airway Pressure device at night, and an interdisciplinary lifestyle modification program. The purpose is to find which approach best reduces breathing interruptions and improves overall health.

Participants will be followed for about 24 weeks. At the start and during the study, the number of breathing pauses per hour of sleep, called the Apnea-Hypopnea Index, will be measured to see how the breathing pattern changes. Daytime sleepiness will be assessed with a questionnaire known as the Epworth Sleepiness Scale, and overall sleep quality will be evaluated using the Pittsburgh Sleep Quality Index. Changes in body weight and the Body Mass Index—a calculation that relates weight to height—will also be recorded. Cognitive function will be checked with the Montreal Cognitive Assessment, a brief test of memory and thinking skills. Safety will be monitored by recording any adverse events that occur during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    A comprehensive set of measurements is performed before any treatment begins. these include the apnea-hypopnea index (a count of breathing interruptions during sleep), the epworth sleepiness scale (a questionnaire about daytime sleepiness), the pittsburgh sleep quality index (a questionnaire about sleep quality), body weight, body mass index (bmi), and the montreal cognitive assessment (a test of mental function).

    The information collected at this visit serves as the reference point for all later comparisons.

  2. Step 2

    Randomization

    After the baseline measurements, you are placed into one of three groups by a computer program. the groups are: the tirzepatide injection group, the cpap (continuous positive airway pressure) group, and the interdisciplinary lifestyle modification group.

  3. Step 3

    Start of treatment

    If assigned to the tirzepatide group, you receive a solution for injection that contains 1.43 mg of tirzepatide. the injection is given under the skin (subcutaneous use) and is continued for a total of 24 weeks.

    If assigned to the cpap group, you begin using a cpap device each night. the device delivers continuous positive airway pressure to keep the airway open during sleep for the full 24‑week period.

    If assigned to the interdisciplinary lifestyle modification group, you start a program that includes diet advice, physical‑activity guidance, and regular counseling sessions. the program continues for the entire 24‑week study period.

  4. Step 4

    Regular follow‑up visits

    You attend clinic visits approximately every four weeks (weeks 4, 8, 12, 16, 20, and 24). during each visit, safety is checked, any side effects are recorded, and the study staff reviews how the treatment is being used.

    The same set of questionnaires and measurements (including the apnea-hypopnea index, epworth sleepiness scale, pittsburgh sleep quality index, weight, bmi, and montreal cognitive assessment) may be repeated at selected visits to monitor progress.

  5. Step 5

    Final assessment

    At week 24, a final comprehensive assessment is performed. all baseline measurements are repeated to determine changes in the apnea-hypopnea index, daytime sleepiness, sleep quality, body weight, bmi, and cognitive function.

    The occurrence and severity of any adverse events or serious adverse events are also documented for the entire 24‑week period.

  6. Step 6

    Study completion

    After the final assessment, the study participation ends. the collected data are used to compare the effectiveness of the three treatment approaches.

Who can join the trial?

5 criteria

  • Be 65 years of age or older.
  • Have a doctor’s diagnosis of moderate‑to‑severe Obstructive Sleep Apnea (OSA), which means breathing stops or becomes very shallow during sleep enough to be considered moderate or severe, measured by an Apnea‑Hypopnea Index (AHI) of 15 or more events per hour (an “event” is a pause or shallow breathing episode).
  • Have a Body Mass Index (BMI) of 27 kg/m² or higher (BMI is a number calculated from height and weight that shows if a person is overweight or obese).
  • Be able to use either CPAP therapy (a machine that provides continuous positive airway pressure to keep the airway open while sleeping) or take part in a lifestyle‑modification program that includes diet, exercise, and other health guidance.
  • Be capable of understanding the study and signing a written informed consent form, indicating agreement to participate.

Who cannot join the trial?

7 criteria

  • Use of GLP‑1 receptor agonists or GIP/GLP‑1 receptor agonists (medicines that affect blood sugar) within the three months before screening.
  • Having been diagnosed with Type 1 Diabetes Mellitus (a condition where the body cannot produce insulin).
  • Having a past diagnosis of medullary thyroid carcinoma (a type of thyroid cancer) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (a genetic disorder that causes tumors in hormone‑producing glands).
  • Having a history of chronic pancreatitis (long‑term inflammation of the pancreas).
  • Having severe kidney disease, defined as an estimated glomerular filtration rate (eGFR) lower than 30 mL/min/1.73 m² (a measure of how well the kidneys filter blood).
  • Having experienced a major heart or blood‑vessel problem, such as a heart attack (infarction) or stroke, in the past six months.
  • Any condition that, in the investigator’s opinion, would prevent you from completing the study procedures, for example severe memory or thinking problems (severe cognitive impairment).
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Investigated drugs

Tirzepatide is a medication given as a liquid that you inject under the skin. It helps the body use sugar and can lead to weight loss, which may reduce the severity of sleep‑breathing problems. In this study it is being tested as a first‑line treatment to see if it can lower the number of breathing interruptions during sleep in older adults who are overweight or obese.

Continuous Positive Airway Pressure (CPAP) is a machine that you wear on your face while you sleep. It gently blows air into your airway to keep it open, preventing pauses in breathing that happen with obstructive sleep apnea. The trial uses CPAP as another first‑line option to compare its effect on sleep breathing patterns.

The interdisciplinary lifestyle modification intervention is a program that combines guidance on healthy eating, regular physical activity, weight‑management strategies, and sleep‑hygiene advice. Participants work with a team of specialists to make sustainable changes that can improve weight and overall health, which may also help reduce sleep‑apnea events.

What is already known about the treatment

Mounjaro - The drug is given as a subcutaneous injection, a clear solution that is injected under the skin using a vial. Tirzepatide is an approved medicine for type 2 diabetes and is also used to help people lose weight, with many studies already published. It works by activating two hormone receptors, GLP‑1 and GIP, which lower blood sugar and reduce appetite. It belongs to the class of dual GIP/GLP‑1 receptor agonists, a type of injectable glucose‑lowering medication.

Investigated diseases

  • Obstructive sleep apnea syndrome

    This condition causes the airway to narrow or close repeatedly while a person sleeps, leading to short pauses in breathing. The pauses disrupt normal sleep patterns and often result in frequent awakenings and daytime tiredness. Over time, the frequency and length of these breathing interruptions can increase, especially with advancing age or weight gain. The condition may also cause louder snoring and a feeling of choking or gasping during sleep.

  • Obesity

    Obesity is a condition characterized by an excessive amount of body fat, typically measured by a body mass index of 30 or higher. It usually develops gradually when more calories are consumed than are burned over a long period. As the amount of body fat increases, the condition can become more pronounced and may affect many aspects of daily life. The excess weight often adds strain to the body and can lead to reduced mobility and comfort.

Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2026-525500-10-00Protocol codeSAMUELEstimated enrolment345 patientsSponsorInstitut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

sourced from the EU Clinical Trials Register and site verification

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