Do you suffer from insomnia?
Would you like to participate in one of our sleep studies and be part of our research looking at an investigational treatment for insomnia? You can do this by joining a clinical study at our specialist centre in Guildford.
The main goal of this study is to compare an investigational treatment for insomnia called lemborexant of two different strengths with another drug called zolpidem tartrate extended release (zolpidem ER), also known as Ambien CR®, and placebo.
We are currently looking for healthy males aged 65 or over, and healthy females aged 55 or over, who suffer from insomnia. For this study a person with insomnia is defined as a person who has difficulty staying asleep and/or awakening earlier in the morning than desired. This difficulty in sleeping must occur at least three times per a week and have been occurring for at least three months prior to study enrolment. If you suffer from any other type of sleeping disorder you will not be eligible for this study. You should have a regular bedtime between 9pm and 12am, and sleep or attempt to sleep between 7 and 9 hours a night.
To be eligible to take part you must be:
- A Healthy Male aged 65 or over or female aged 55 or over
- Suffering from difficulties staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep. Happening at least 3 times a week and for at least 3 months.
- Have not been diagnosed with any sleep disorders other than insomnia.
- Having a regular bedtime between 9pm and midnight, and either sleeping or trying to sleep between 7 and 9 hours.
- Available for the duration of the study (approximately 11.5 weeks).
- Be registered with a GP.
- Not have taken part in another clinical trial in the last 30 days.
The study comprises of 9 visits to Surrey CRC. You must be available for the whole duration of the study (approximately 11.5 weeks from screening). During the first visit you will be seen by one of the Research Centre’s doctors; a full explanation of the study will be given, you will go through the consent process and you will be asked to give details of your medical history during the medical screening. Routine blood tests will be taken to test for HIV, Hepatitis B & C and urine samples taken to test for drugs of abuse. Your vital signs (heart rate, breathing rate, blood pressure and oral temperature), and ECG (a recording of the electrical activity of your heart), your height and weight will be measured and the study doctor will perform a routine physical examination to evaluate your health. You will be required to complete questionnaires about your health and sleep patterns. If you decide to take part in the study your GP will be contacted, with your permission, in order to notify him/her of your participation.
If you meet the criteria to take part, you will be invited in for a 1 night sleep assessment before being accepted onto the study. This will allow you to get used to the study sleep labs and we will also check for presence of any sleep disorders, which might exclude you from the study. Your sleep will be monitored and recorded during the night using electrodes attached to your body and scalp (using a water soluble paste); this is called polysomnography (PSG). The PSG will record brain and muscle activities, eye movement, heart activity, airflow and any changes in your sleep or wakefulness.
If you are still eligible, you will be randomly assigned to one of the treatment groups, but you will not know which medication you are receiving. You will be required to take the medication for 30 days at home immediately before bed. During this time you will complete 3 residential stays (visits 3-8) which each consist of a two night stay spread over approximately 6 weeks. During your residential stays you will be required to wear the electrodes as your sleep will be recorded. Your 9th and final visit will be a follow-up visit; it will be scheduled approximately 2 weeks after the last treatment night. You be carefully monitored throughout the study period by our experienced clinical staff and doctors.
You will be reimbursed for each overnight stay you have, plus reasonable travel expenses will be provided for your visits.
If you have already registered with us or have previously taken part in a study at the CRC please click "already registered" to express your interest. If you have not previously registered please click the "new participant application form".
If you would like more information under no obligation, or are interested in taking part, please contact the Clinical Research Recruitment team on: Freephone 0800 269 847, by email firstname.lastname@example.org.