Intervention Study in Elderly With Sleep Problems

NCT05485415 | Active Not Recruiting DMC

• 1 other identifier: 2022-00904
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to improve subjective sleep quality using a multimodal intervention with an intervention and a control group. The multimodal intervention aims to improve circadian Zeitgeber strength. This will be achieved by optimizing daily light exposure, sleep, physical activity, and mealtimes.

Conditions

Sleep Disturbance

Keywords

circadian; light; cognition; Zeitgeber; personalized; health; sleep; muliti-modal

Outcome Measures

Primary Outcomes (1)

• Subjective sleep quality

  Pittsburgh Sleep Quality Index (Score \> 5 indicates poor sleep)

  6 months

Secondary Outcomes (7)

• Sleep timing

  6 months

• Subjective wellbeing

  6 months

• Salivary melatonin concentration

  6 months

• Pupil size

  6 months

• Glucose metabolism

  6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Personalised intervention

Behavioral: Multimodal intervention

Control

PLACEBO COMPARATOR

General sleep advice

Behavioral: Control

Interventions

Multimodal intervention BEHAVIORAL

Participants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity.

Intervention

Control BEHAVIORAL

General sleep advice

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• at least 65 years old women and men
• Pittsburgh Sleep Quality Index (PSQI) \> 5 (indicative of sleep problems)
• Living at home (including self-serviced retirement apartment)

You may not qualify if:

• Total blindness or VA \< 0.5
• Progressive NCDs (e.g., cancer)
• Acute infections (e.g., Covid-19)
• Neurodegenerative disease
• Psychiatric disease
• Sleep disorder (sleep apnea, narcolepsy)
• Not German speaking

Sponsors & Collaborators

• Mirjam Münch: lead
• University of California: collaborator

Study Sites (1)

Centre for Chronobiology, Psychiatric Hopspital of the University of Basel

Basel, 4002, Switzerland

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mirjam Münch, PhD

  Research Associate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unaware whether they are in the intervention or the control group
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Clinical Trial with a control group

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: August 3, 2022
• Study Start: July 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)