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DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

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Studies 458
Trials 82
Active Not Recruiting NA INTERVENTIONAL NCT06544213

A 60 Days Head Down Tilt Bedrest With Artificial Gravity and Cycling Exercise on 24 Healthy Male (BRACE)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The objective of this study is to investigate whether a cycling exercise coupled with artificial gravity via a short-arm human centrifuge helps to prevent and / or reduce the deleterious effects induced by 60 days of anti-orthostatic bedrest. The secondary objective is to investigate whether the combination of a supine cycling exercise with artificial gravity is more effective than the same supine cycling exercise alone in preventing or reducing the effects of head-down bedrest. During a randomized, 60 day bed rest study, in 24 healthy male adults, the two following aims will be undertaken: * Fourteen scientific protocols will assess the changes in the cardiovascular, metabolic, musculoskeletal, neuro-sensorial, haematological, and immunological systems. * In the above-mentioned systems, the comparative potential beneficial effects of the two countermeasure protocols will also be investigated by the scientific protocols and bedrest standard measurements (BSM).

Detailed Description

Space flights have shown the possibilities and limitations of human adaptation to space. For the last 60 years, results have shown that the space environment and microgravity in particular, cause changes that may affect the performance of astronauts. These physiological changes are now better known: prolonged exposure to weightlessness can lead to significant loss of bone and muscle mass, strength, cardiovascular and sensory-motor deconditioning, immune, hormonal and metabolic changes . Moreover, recently a new suite of physiological adaptations and consequences of space flight has been acknowledged. Indeed, after long flights, some astronauts present persistent ophthalmologic changes, mostly a hyperopic shift, an increase in optic nerve sheath diameter and occasionally a papillary oedema now defined by National Aeronautics and Space Administration (NASA) as Spaceflight-Associated Neuro-ocular Syndrome (SANS). Some of these vision changes remain unresolved for years post-flight. This phenomenon has most likely existed since the beginning of human space flight but is just recently being recognized as a major consequence of adaptation to microgravity. Overall, spaceflight induces physiological multi-system deconditioning which may impact astronauts' efficiency and create difficulties upon their return to normal gravity. Understanding the underlying mechanisms of these processes and developing efficient countermeasures to prevent, limit or reverse this deconditioning remain important challenges and major priorities for manned space programs. The space agencies are actively engaged in studying the physiological adaptation to space environment through studies on board the International Space Station (ISS) but also on the ground. Indeed, considering the limited number of flight opportunities, the difficulties related to the performance of in-flight experiments (operational constraints for astronauts, limited capabilities of in-flight biomedical devices), ground-based experiments simulating the effects of weightlessness are used to better understand the mechanisms of physiological adaptation, design and validate the countermeasures. Different methods are used to simulate microgravity on Earth. However, two approaches, -6° head-down bed rest (HDBR) and dry immersion (DI) have provided possibilities for long-term exposures with findings closest to those seen with a weightless state. They produce changes in body composition (including body fluid redistribution), cardiovascular and skeletal muscle characteristics that resemble the effects of microgravity. One of the advantages of the HDBR model is that it has now been used in a great number of studies internationally, and its effects have long been described and compared with those of microgravity and spaceflight. Long-term bedrest is the gold-standard method for studying the effects of weightlessness and to test countermeasures. The HDBR, as the name implies, implicates a long (from several weeks to a year) stay in the supine position, the head tilted down by -6° from the horizontal plane. HDBR is the most frequently used ground-based simulation for gravitational unloading of the human body in western countries. During human space missions, the current most effective countermeasure is physical exercise. However, it is both time-consuming and not completely satisfactory. One of the solutions for this is to combine physical exercise with artificial gravity, with the use of a short-arm human centrifuge (SAHC). This study proposes to test the effectiveness of a countermeasure protocol combining Artificial Gravity (AG) with a cycling exercise, and to compare it with only a cycling exercise, and with a complete lack of physical exercise.

Interventions

Name: Control Group
Type: BEHAVIORAL
Description: 60 days of strict head down tilt bed rest at all time. No countermeasure program is performed.
Name: Countermeasure Supine Bike
Type: BEHAVIORAL
Description: 60 days of strict head down tilt bed rest at all time. The exercise starts at 40% of VO2max for 5 minutes, followed by a series of 2-minute high- and low-intensity intervals for 20 minutes. 2-minute high-intensity intervals are at 65% VO2max, 70% VO2max, 80% VO2max, 80% VO2max, 70% VO2max and 65% VO2max. 2-minute low-intensity intervals are at 40% VO2max. 3 minutes at 40% of VO2max will end the exercise. VO2max is measured for each volunteer in supine position.
Name: Countermeasure AG-Bike
Type: BEHAVIORAL
Description: 60 days of strict head down tilt bed rest at all time. The exercise starts at 40% of VO2max for 5 minutes, followed by a series of 2-minute high- and low-intensity intervals for 20 minutes. 2-minute high-intensity intervals are at 65% VO2max, 70% VO2max, 80% VO2max, 80% VO2max, 70% VO2max and 65% VO2max. 2-minute low-intensity intervals are at 40% VO2max. 3 minutes at 40% of VO2max will end the exercise. VO2max is measured for each volunteer in supine position. The supine bike exercise is performed in a short arm centrifuge in rotation. Volunteers will start pedalling and the centrifuge will start at 0.15 Gz less than individual's threshold. Every 4 minutes thereafter, the AG will be increased by 0.15 Gz, synchronized with the ramping up of cycle ergometer interval intensity. The AG will increase only up to 70 % of their tolerance level,. It will then decrease by 0.15 Gz every 4 minutes, and until the 30-minute exercise is completed.

Primary Outcomes

Measure: Changes in orthostatic tolerance
TimeFrame: At baseline and first day of recovery
Description: Orthostatic tolerance will be assessed during a tilt test combined with Lower Body Negative Pressure test (LBNP test)
Measure: Changes in peak aerobic power (VO2max test)
TimeFrame: At baseline and end of head down tilt phase at week 10
Description: Exercise capacity wil be assessed by graded cycling on sitting ergometer until exhaustion
Measure: Changes in plasma volume
TimeFrame: At baseline and end of head down tilt phase at week 10
Description: Plasma volume (L) will be assessed by the carbon monoxide-rebreathing method
Measure: Changes in serum bone formation markers
TimeFrame: From baseline until the end of the volunteers' participation in the study at year 2
Description: Change in bone-specific Alkaline Phosphatase (bAP, µg/L) and procollagen type I N-terminal propeptide (P1NP, µg/L) will be assessed by chemiluminescence immunoassay
Measure: Change in serum bone resorption markers
TimeFrame: From baseline until the end of the volunteers' participation in the study at year 2
Description: Change in C-terminal cross-linked telopeptide of type I collagen (CTx, pmol/L) and N-terminal cross-linked telopeptide of type I collagen (NTX, pmol/L) will be assessed by chemiluminescence immunoassay.
Measure: Changes in Resting Metabolic Rate (RMR)
TimeFrame: At baseline and at recovery at week 12
Description: RMR will be measured by indirect calorimetry technique
Measure: Change in nitrogen balance
TimeFrame: At baseline and at recovery at week 12
Description: Nitrogen balance is a measure of nitrogen input minus nitrogen output. Nitrogen intake is calculated with a nutrition software. Protein oxidation measured in the 24-Hour urine collection estimates nitrogen output.
Measure: Change in muscle strength
TimeFrame: At baseline and at recovery at week 10
Description: Muscle strength will be assessed from single leg isometric maximal voluntary contraction on the knee extensors \& flexors, the plantarflexors and dorsiflexors. The Isometric Torque will be measured in Nm. The peak of the three maximal attempts will be recorded for strength measures
Measure: Change in fat and lean body mass measured by dual energy x-ray absorptiometry (DEXA)
TimeFrame: From baseline until the end of the volunteers' participation in the study at year 2
Description: Dual energy x-ray absorptiometry is a standard clinical technique to assess fat (g) and lean (g) body mass.
Measure: Change in walking balance
TimeFrame: At baseline and at recovery at week 10
Description: Functional mobility test (such as sit and walk, heel to toe steps with eyes closed and open) will assess walking balance
Measure: Changes in jump performance
TimeFrame: At baseline and at recovery at week 12
Description: Jump performance will be assessed on a platform and height of the jump will be evaluated
Measure: Change in standing balance
TimeFrame: At baseline and at recovery at week 10
Description: Standing balance will be assessed by posturography eyes open and eyes closed on a platform covered with 12-cm thick medium density foam
Measure: Changes in leg muscle volume and fat
TimeFrame: At baseline and at recovery at week 10
Description: MRI of the lower extremity will assess the degree of atrophy and changes in fat content in the musculature
Measure: Changes in bone density (by DEXA and High Resolution Peripheral Computed Tomography (HR-pQCT))
TimeFrame: From baseline until the end of the volunteers' participation in the study at year 2
Description: Bone density is measured at lumbar and hip level with DEXA and at tibia and radius level with HR-pQCT
Measure: Change in the optic nerve fibers thickness
TimeFrame: At baseline and at recovery at week 12
Description: Thickness of the optic nerve fibers will be measured by Optical Coherence Tomography (OCT)
Measure: Change in intraocular pressure (IOP)
TimeFrame: At baseline and at recovery at week 12
Description: IOP is measured with air tonometry
Measure: Change in visual acuity
TimeFrame: At baseline and at recovery at week 12
Description: Far and near visual acuity are tested uncorrected, or if applicable with own correction with digital acuity system
Measure: Change in visual field
TimeFrame: At baseline and at recovery at week 12
Description: Visual field measured by standard automated perimetry
Measure: Change in the anatomical characteristics of the eye (optical biometry)
TimeFrame: At baseline and at recovery at week 12
Description: Optical biometry measured by partial coherence interferometry
Measure: Change in the central corneal thickness
TimeFrame: At baseline and at recovery at week 12
Description: Central corneal thickness on a single point on the cornea measured by Ultrasonic pachymetry
Measure: Change in the retina by non-mydriatic fundus retinography
TimeFrame: At baseline and at recovery at week 12
Description: Non-mydriatic fundus retinography allows a fundus photography to be taken and thus a color image of the papilla, retinal vessels and macula
Measure: Change in the cornea topography
TimeFrame: At baseline and at recovery at week 12
Description: Cornea topography measured by corneal topography equipment (like Pentacam). The elevation topography allows the mapping of the anterior and posterior surface of the cornea.
Measure: Change in motion sickness susceptibility
TimeFrame: At baseline and at recovery at week 12
Description: Assessed by the Motion Sickness Susceptibility Questionnaire Short form (MSSQ-Short). MSSQ-Short scores possible range from minimum 0 to maximum 54, the maximum being unlikely. Higher scores means a higher motion sickness susceptibility
Measure: Change in fluid shift distribution towards the cardiac and cephalic region
TimeFrame: At baseline and until year 1
Description: The consequences of the fluid shift on the cardiac and cephalic area will be assessed by quantifying the right and left Jugular veins volumes (mL), as well as the left ventricle diastolic/systolic volumes (mL) by ultrasound.
Measure: Change in mood
TimeFrame: At baseline and until week 12
Description: Change in mood is assessed using the Profile of Mood States (POMS) questionnaire. POMS questionnaire gives 6 measures of mood: Tension/anxiety, Depression, Anger/hostility Dynamism, Fatigue, Confusion A Total Mood Disturbance (TMD) score is calculated by summing the totals for the negative subscales (tension, depression, fatigue, confusion, anger) and then subtracting the totals for the positive subscale (vigor /esteem-related affect).
Measure: Change in affective states
TimeFrame: At baseline and until week 12
Description: Positive and Negative Schedule (PANAS) questionnaire will be used to assess the intensity of positive and negative affective states. PANAS self-report questionnaire consists of two 10-item scales to measure both positive and negative affects Each item is rated on a five-point Likert Scale, ranging from 1 = Not at all to 5 = Extremely, to measure the extent to which the affect has been experienced in a specified time frame. Positive affects: scores can range from 10 - 50 with higher scores representing higher levels of positive affect. Negative affects: scores can range from 10 - 50 with higher scores representing higher levels of negative affect.
Measure: Change in sleep quality
TimeFrame: At baseline and until week 12
Description: Pittsburgh Sleep Dairy (PghSD) will be used to assess sleep perceived quality. The PghSD is an instrument with separate components to be completed at bedtime and wake time. The following parameters are registered or assessed: Bedtime, wake time, sleep latency, wake after sleep onset, total sleep time, mode of awakening and ratings of sleep quality, mood, and alertness on wakening, as well as daytime information on naps, exercise, meals and caffeine, tobacco and medications use.
Measure: Change in psychological state: mental health
TimeFrame: At baseline and until week 12
Description: General Health Questionnaire-28 (GHQ-28) will be used to assess psychological well-being and capture distress GHQ-28 gives an overall total score and 4 scores for 4 subscales: Somatic symptoms, Anxiety/insomnia, Social dysfunction, Severe depression. Higher scores indicate higher levels of distress
Measure: Measurement of changes in subjective sleep quality
TimeFrame: At baseline and until week 12
Description: Changes in subjective sleep quality will be measured using the Karolinska sleepiness scale (KSS) two times per day (bed time) every week.

Trial Information

NCT ID

NCT06544213

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Centre National d'Etudes Spatiales

Last Updated

December 15, 2025